Speakers
Patricia L. Alcock, Director, Division of Human Resource Development, Office of Regulatory Affairs, FDA
Patricia Alcock received a Bachelor's degree in biology from Lycoming College, Williamsport, PA in 1989. That same year, Ms. Alcock started her career with the Food and Drug Administration as an Investigator with the New Jersey District. From 1989 thru 1996, Ms. Alcock acquired multi-district experience, working in New Jersey District as drug investigator, and then in San Juan District as a Drug Specialist Investigator, with a primary focus on pharmaceutical manufacturing inspections. From 1996 to 1999, Ms. Alcock was promoted to CDER's Office of Compliance and served as a Compliance Officer reviewing inspection reports for compliance to FDA regulations. In August 2002, Ms. Alcock returned to FDA's Office of Regulatory Affairs as Deputy Director of the Division of Field Investigations; where her role was to manage the National Expert Investigators and assist ORA's Field Offices on inspectional matters. Ms. Alcock is currently the Director at FDA ORA's Division of Human Resource Development and assisted in the day to day operations of a large training and certification organization. DHRD's primary role is to analyze, design, develop, implement and evaluate adult education, training and certification programs for FDA ORA employees. In addition to assisting FDA ORA employees, DHRD is works collaboratively with FDA's state, local, tribal and territory regulatory partners in providing education and training programs for their inspection staff in support of public health protection.
Patricia Alcock received a Bachelor's degree in biology from Lycoming College, Williamsport, PA in 1989. That same year, Ms. Alcock started her career with the Food and Drug Administration as an Investigator with the New Jersey District. From 1989 thru 1996, Ms. Alcock acquired multi-district experience, working in New Jersey District as drug investigator, and then in San Juan District as a Drug Specialist Investigator, with a primary focus on pharmaceutical manufacturing inspections. From 1996 to 1999, Ms. Alcock was promoted to CDER's Office of Compliance and served as a Compliance Officer reviewing inspection reports for compliance to FDA regulations. In August 2002, Ms. Alcock returned to FDA's Office of Regulatory Affairs as Deputy Director of the Division of Field Investigations; where her role was to manage the National Expert Investigators and assist ORA's Field Offices on inspectional matters. Ms. Alcock is currently the Director at FDA ORA's Division of Human Resource Development and assisted in the day to day operations of a large training and certification organization. DHRD's primary role is to analyze, design, develop, implement and evaluate adult education, training and certification programs for FDA ORA employees. In addition to assisting FDA ORA employees, DHRD is works collaboratively with FDA's state, local, tribal and territory regulatory partners in providing education and training programs for their inspection staff in support of public health protection.
Courtney Bidney, General Mills, Director, Global Regulatory Affairs and International Nutrition
Courtney is the Director of Global Regulatory Affairs and International Nutrition and has responsibility for influencing and leading global product and food safety regulatory policy and leading international nutrition for General Mills As part of this role, Courtney is responsible for leading the International Health and Wellness Network to include innovation, communication and regulatory aspects while also preparing for implementation of new regulations from the U.S. Food Safety Modernization Act. In addition, Courtney is responsible for global food safety and regulatory policies.
Courtney began her career at General Mills in 1999 as a summer intern and later progressed through Quality Engineer and Manager roles across multiple locations and divisions. In 2009, Courtney began a cross-functional assignment as an Operations Business Manager (OBM) in the Snacks Division. Following that, she joined the Central Quality and Regulatory Operations team and focused on policy, metrics, and corporate verification.
Courtney serves on the Grocery Manufacturers Association (GMA) Scientific and Regulatory Affairs Council. In addition, Courtney is the Industry Liaison for the North Central Association of Food and Drug Officials (NCAFDO). Courtney recently completed a two year term as chair of the GMA Regulatory Inspection and Compliance Committee (RICC). Courtney holds a Bachelor’s degree in Nutritional Sciences from Texas A&M University and a MS Degree in Food Science from Ohio State University. In her free time, Courtney enjoys spending time with her husband and two small children, Jackson and Madeline.
Courtney is the Director of Global Regulatory Affairs and International Nutrition and has responsibility for influencing and leading global product and food safety regulatory policy and leading international nutrition for General Mills As part of this role, Courtney is responsible for leading the International Health and Wellness Network to include innovation, communication and regulatory aspects while also preparing for implementation of new regulations from the U.S. Food Safety Modernization Act. In addition, Courtney is responsible for global food safety and regulatory policies.
Courtney began her career at General Mills in 1999 as a summer intern and later progressed through Quality Engineer and Manager roles across multiple locations and divisions. In 2009, Courtney began a cross-functional assignment as an Operations Business Manager (OBM) in the Snacks Division. Following that, she joined the Central Quality and Regulatory Operations team and focused on policy, metrics, and corporate verification.
Courtney serves on the Grocery Manufacturers Association (GMA) Scientific and Regulatory Affairs Council. In addition, Courtney is the Industry Liaison for the North Central Association of Food and Drug Officials (NCAFDO). Courtney recently completed a two year term as chair of the GMA Regulatory Inspection and Compliance Committee (RICC). Courtney holds a Bachelor’s degree in Nutritional Sciences from Texas A&M University and a MS Degree in Food Science from Ohio State University. In her free time, Courtney enjoys spending time with her husband and two small children, Jackson and Madeline.
Evelyn Bonnin, District Director, Baltimore District Office, FDA
Ms. Bonnin is responsible for executive leadership and overall management of the Baltimore District, Food and Drug Administration. The District is responsible for FDA's investigational and enforcement activities in Maryland, Virginia, West Virginia, and the District of Columbia. In addition, the District conducts outreach activities to promote voluntary compliance and consumer understanding about matters regulated by the agency.
Ms. Bonnin received a B.S. degree in chemistry from the University of Puerto Rico in 1978. She joined FDA as a chemist in the Forensic Chemistry Center, Cincinnati in 1980 until 1983. She served as a chemist in the Atlanta Center for Nutrient Analysis (ACNA) from 1992 to 1993 and was appointed Technical Assistance and Quality Assurance Coordinator for the Southeast Regional Laboratory, Atlanta, GA in 1994. In 1999 she was selected for the ACNA Director position. Ms. Bonnin assumed her current position in November 2005.
Ms. Bonnin also has over twelve years of experience working with the private industry, mainly pharmaceuticals companies, and is a graduate of the FDA Leadership Development Program, 1997-1999.
Ms. Bonnin is responsible for executive leadership and overall management of the Baltimore District, Food and Drug Administration. The District is responsible for FDA's investigational and enforcement activities in Maryland, Virginia, West Virginia, and the District of Columbia. In addition, the District conducts outreach activities to promote voluntary compliance and consumer understanding about matters regulated by the agency.
Ms. Bonnin received a B.S. degree in chemistry from the University of Puerto Rico in 1978. She joined FDA as a chemist in the Forensic Chemistry Center, Cincinnati in 1980 until 1983. She served as a chemist in the Atlanta Center for Nutrient Analysis (ACNA) from 1992 to 1993 and was appointed Technical Assistance and Quality Assurance Coordinator for the Southeast Regional Laboratory, Atlanta, GA in 1994. In 1999 she was selected for the ACNA Director position. Ms. Bonnin assumed her current position in November 2005.
Ms. Bonnin also has over twelve years of experience working with the private industry, mainly pharmaceuticals companies, and is a graduate of the FDA Leadership Development Program, 1997-1999.
Robert Brener, MA, CCC, CCE, CHE, College of Culinary Arts - Associate Professor
Robert Brener ’91 received his master’s degree in 2008. He holds a bachelor’s degree in food service management from the Charleston Campus. Brener spent three years working as a chef in Germany and Ireland after completing his associate degree in culinary arts. Brener’s stateside experience includes: The Inn at Little Washington, sous chef at The Wild Boar in Nashville, Tenn., executive sous chef at Keystone Resort Lodge Dining in Keystone, Colo., and executive chef at The Lodge & Spa in Breckenridge, Colo. He relocated from Birmingham, Ala., where he designed and taught culinary management at Culinard for three years.
Robert Brener ’91 received his master’s degree in 2008. He holds a bachelor’s degree in food service management from the Charleston Campus. Brener spent three years working as a chef in Germany and Ireland after completing his associate degree in culinary arts. Brener’s stateside experience includes: The Inn at Little Washington, sous chef at The Wild Boar in Nashville, Tenn., executive sous chef at Keystone Resort Lodge Dining in Keystone, Colo., and executive chef at The Lodge & Spa in Breckenridge, Colo. He relocated from Birmingham, Ala., where he designed and taught culinary management at Culinard for three years.
Donald Brizes, C.C.C., C.C.E., W.S.E.T., M.S.Ed., CHE, College of Culinary Arts – Associate Professor
Donald Brizes received his master’s degree in secondary education from The University of Akron (UA). He joined the Charlotte Campus in 2005 from Pittsburgh, Pa., where for six years he was the Director of Continuing Education at the Pennsylvania Culinary Institute. In addition, Brizes taught in the associate degree program at UA and was executive chef at the Martin University Center, a public restaurant and banquet facility on campus. Brizes spent more than 27 years working in the Cleveland-Akron area restaurant and hotel industry. Brizes holds a bachelor’s degree in education and an associate degree in hotel restaurant management. He serves as the food safety liaison for the university and sits on the university and college of culinary arts outcomes assessment committees.
Donald Brizes received his master’s degree in secondary education from The University of Akron (UA). He joined the Charlotte Campus in 2005 from Pittsburgh, Pa., where for six years he was the Director of Continuing Education at the Pennsylvania Culinary Institute. In addition, Brizes taught in the associate degree program at UA and was executive chef at the Martin University Center, a public restaurant and banquet facility on campus. Brizes spent more than 27 years working in the Cleveland-Akron area restaurant and hotel industry. Brizes holds a bachelor’s degree in education and an associate degree in hotel restaurant management. He serves as the food safety liaison for the university and sits on the university and college of culinary arts outcomes assessment committees.
Todd Cain, Director General, Health Canada
Todd Cain is Director General of Health Canada’s Medical Devices and Clinical Compliance Directorate. Prior to that, he led both the Review of the Inspection Function and the outreach to the private sector in support of the new Marihuana for Medical Purposes Regulations. His diverse experience includes the public, non-profit and private sectors in consulting and executive leadership roles. His areas of expertise include policy, governance, strategy and mergers/acquisitions, gained from work with Deloitte, the Treasury Board of Canada, General Electric and Ford Motor Company.
He holds a Bachelor of Public Administration, Highest Honours, from Carleton University and a Master’s of Industrial and Labour Relations from Cornell University. He chairs the board of directors of the National Capital YMCA-YWCA.
Todd Cain is Director General of Health Canada’s Medical Devices and Clinical Compliance Directorate. Prior to that, he led both the Review of the Inspection Function and the outreach to the private sector in support of the new Marihuana for Medical Purposes Regulations. His diverse experience includes the public, non-profit and private sectors in consulting and executive leadership roles. His areas of expertise include policy, governance, strategy and mergers/acquisitions, gained from work with Deloitte, the Treasury Board of Canada, General Electric and Ford Motor Company.
He holds a Bachelor of Public Administration, Highest Honours, from Carleton University and a Master’s of Industrial and Labour Relations from Cornell University. He chairs the board of directors of the National Capital YMCA-YWCA.
Steven L. Carter, Director, Compliance Branch, Philadelphia District Office
Steven Carter is the Director of the Compliance Branch (DCB) in the Philadelphia District Office (PHI-DO); a position he has held since November 2004. In that position, Mr. Carter directs Compliance Officers, who possess diverse program backgrounds, and has oversight in their crafting of enforcement actions (on behalf of the district) ranging from warning letters to consent decrees of permanent injunction in the various program areas (e.g., domestic foods, pharmaceuticals, and medical devices) represented in the district’s jurisdiction of Pennsylvania and Delaware. Additionally, Mr. Carter oversees staff, who have responsibilities/involvement in the recall program area for medical product recalls initiated by industry based within the jurisdiction of the district. Prior to assuming the DCB position, in 1998, Mr. Carter began serving as a Supervisory Investigator in the PHI-DO Investigations Branch, overseeing the work activities and accomplishments as well as the development of field staff assigned to various program areas such as pharmaceuticals, high risk foods, medical devices, biologics, as well as bio-research monitoring assignments. Mr. Carter began his FDA career in 1988 as an Consumer Safety Officer/Investigator in the New Jersey District, where he obtained the knowledge and skills to conduct inspections in all program areas (e.g., bioresearch monitoring (clinical trials, IRBs), pharmaceuticals (APIs, oral finished dosage, medical gases, and sterile liquid parenterals-injectables, and etc.), medical devices, domestic foods, blood banks, cosmetics and tissue residue investigations), and on occasions, conducted special investigations into high profile suspect tampering cases. Mr. Carter attended Rutgers University, as a biology/pre-med major, but obtained a bachelor’s of science degree from Geneva College and a master’s of science degree from Cairn University in organizational development/leadership.
Steven Carter is the Director of the Compliance Branch (DCB) in the Philadelphia District Office (PHI-DO); a position he has held since November 2004. In that position, Mr. Carter directs Compliance Officers, who possess diverse program backgrounds, and has oversight in their crafting of enforcement actions (on behalf of the district) ranging from warning letters to consent decrees of permanent injunction in the various program areas (e.g., domestic foods, pharmaceuticals, and medical devices) represented in the district’s jurisdiction of Pennsylvania and Delaware. Additionally, Mr. Carter oversees staff, who have responsibilities/involvement in the recall program area for medical product recalls initiated by industry based within the jurisdiction of the district. Prior to assuming the DCB position, in 1998, Mr. Carter began serving as a Supervisory Investigator in the PHI-DO Investigations Branch, overseeing the work activities and accomplishments as well as the development of field staff assigned to various program areas such as pharmaceuticals, high risk foods, medical devices, biologics, as well as bio-research monitoring assignments. Mr. Carter began his FDA career in 1988 as an Consumer Safety Officer/Investigator in the New Jersey District, where he obtained the knowledge and skills to conduct inspections in all program areas (e.g., bioresearch monitoring (clinical trials, IRBs), pharmaceuticals (APIs, oral finished dosage, medical gases, and sterile liquid parenterals-injectables, and etc.), medical devices, domestic foods, blood banks, cosmetics and tissue residue investigations), and on occasions, conducted special investigations into high profile suspect tampering cases. Mr. Carter attended Rutgers University, as a biology/pre-med major, but obtained a bachelor’s of science degree from Geneva College and a master’s of science degree from Cairn University in organizational development/leadership.
Barbara Cassens, Director of the Office of Partnerships, Office of Regulatory Affairs, FDA
Ms. Barbara Cassens is the Director for the Office of Partnerships within FDA’s Office of Regulatory Affairs. She has held this position as the acting director since February 2013, and as the permanent position since 2016. Her office supports enhanced investments in federal-state-local collaboration, integration and manufactured human and animal food standards. Ms. Cassens has been with the U.S. Food and Drug Administration since 1990 starting as a field investigator and then assuming the roles of marine biotoxin coordinator, dairy specialist, Pacific Region Cooperative Programs Director and San Francisco District Director. Her past work has included a number of federal-state integration projects such as joint work planning and development of the first federal-state food emergency response team, CALFERT. She also leads a Food Safety Modernization Act (FSMA) team in implementation of inspection and compliance portions of the rule. In 2010 she was lead of a multi-disciplinary FDA team for designing new approaches to inspections and compliance within the foods program. Prior to joining the federal government, Ms. Cassens worked as a food technologist and program manager in research and development/quality assurance for Nestle, Dole Packaged Foods, and John Labatt Limited. She holds a Bachelors of Science Degree, Food Science Curriculum, from Iowa State University. Ms. Cassens is former president of the Western Association of Food and Drug Officials and is active in the parent organization, AFDO, as well as being a member of the Institute of Food Technologists and the International Association for Food Protection.
Ms. Barbara Cassens is the Director for the Office of Partnerships within FDA’s Office of Regulatory Affairs. She has held this position as the acting director since February 2013, and as the permanent position since 2016. Her office supports enhanced investments in federal-state-local collaboration, integration and manufactured human and animal food standards. Ms. Cassens has been with the U.S. Food and Drug Administration since 1990 starting as a field investigator and then assuming the roles of marine biotoxin coordinator, dairy specialist, Pacific Region Cooperative Programs Director and San Francisco District Director. Her past work has included a number of federal-state integration projects such as joint work planning and development of the first federal-state food emergency response team, CALFERT. She also leads a Food Safety Modernization Act (FSMA) team in implementation of inspection and compliance portions of the rule. In 2010 she was lead of a multi-disciplinary FDA team for designing new approaches to inspections and compliance within the foods program. Prior to joining the federal government, Ms. Cassens worked as a food technologist and program manager in research and development/quality assurance for Nestle, Dole Packaged Foods, and John Labatt Limited. She holds a Bachelors of Science Degree, Food Science Curriculum, from Iowa State University. Ms. Cassens is former president of the Western Association of Food and Drug Officials and is active in the parent organization, AFDO, as well as being a member of the Institute of Food Technologists and the International Association for Food Protection.
Alonza Cruse
Alonza Cruse is the Pharmaceutical Quality Program Director within FDA’s Office of Regulatory Affairs (ORA). This office is responsible for all pharmaceutical quality inspections, investigations, compliance and related activities, foreign and domestic, working in conjunction with FDA’s Center for Drug Evaluation and Research and the Center for Veterinary Medicine. Additionally, Alonza is leading ORA’s efforts under FDA’s program alignment initiative for pharmaceutical quality. Program Alignment is intended to facilitate operational and policy activities as FDA transitions to a distinct commodity-based and vertically-integrated pharmaceutical regulatory program.
Prior to his current position, Alonza served as the Director (Acting) of the Office of Medical Products and Tobacco Operations (OMPTO) within FDA’s Office of Regulatory Affairs (May 2013- March 2015). Under his leadership, this office provided, developed, and/or evaluated agency policy and procedures for investigations/inspections of establishments in the Medical Products area (Drugs, Devices, Biologics, BIMO and Tobacco) to ensure compliance with laws and regulations administered by the Agency.
Alonza Cruse is the former Director (Oct 2000-Oct 2015) of FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to one of the largest District Offices within FDA’s Office of Regulatory Affairs. Mr. Cruse implemented, managed and evaluated FDA's regulatory operations within the District, which is comprised of the State of Arizona and southern California including the ports of Los Angeles, Long Beach and an International Mail Facility. He also serves as an advisor to University of Southern California (USC) School of Pharmacy’s Regulatory Sciences Master’s program. He is the past President (2005-2006) of the Western Association of Food & Drug Officials (WAFDO).
Alonza Cruse is the Pharmaceutical Quality Program Director within FDA’s Office of Regulatory Affairs (ORA). This office is responsible for all pharmaceutical quality inspections, investigations, compliance and related activities, foreign and domestic, working in conjunction with FDA’s Center for Drug Evaluation and Research and the Center for Veterinary Medicine. Additionally, Alonza is leading ORA’s efforts under FDA’s program alignment initiative for pharmaceutical quality. Program Alignment is intended to facilitate operational and policy activities as FDA transitions to a distinct commodity-based and vertically-integrated pharmaceutical regulatory program.
Prior to his current position, Alonza served as the Director (Acting) of the Office of Medical Products and Tobacco Operations (OMPTO) within FDA’s Office of Regulatory Affairs (May 2013- March 2015). Under his leadership, this office provided, developed, and/or evaluated agency policy and procedures for investigations/inspections of establishments in the Medical Products area (Drugs, Devices, Biologics, BIMO and Tobacco) to ensure compliance with laws and regulations administered by the Agency.
Alonza Cruse is the former Director (Oct 2000-Oct 2015) of FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to one of the largest District Offices within FDA’s Office of Regulatory Affairs. Mr. Cruse implemented, managed and evaluated FDA's regulatory operations within the District, which is comprised of the State of Arizona and southern California including the ports of Los Angeles, Long Beach and an International Mail Facility. He also serves as an advisor to University of Southern California (USC) School of Pharmacy’s Regulatory Sciences Master’s program. He is the past President (2005-2006) of the Western Association of Food & Drug Officials (WAFDO).
Karen Daugherty,Director, Investigations Branch, FDA/Dallas District
Karen Curtis Daugherty is the Director, Investigations Branch, FDA/Dallas District, Dallas, Texas. She has been in her current position since October 2014. Prior to this position she served the Dallas District as a Supervisory Investigator and as an Investigator. She began her career with FDA in 1991, and has a breadth of experience conducting foreign and domestic inspections in multiple program areas, including foods, drugs, and clinical bioresearch monitoring.
Karen Curtis Daugherty is the Director, Investigations Branch, FDA/Dallas District, Dallas, Texas. She has been in her current position since October 2014. Prior to this position she served the Dallas District as a Supervisory Investigator and as an Investigator. She began her career with FDA in 1991, and has a breadth of experience conducting foreign and domestic inspections in multiple program areas, including foods, drugs, and clinical bioresearch monitoring.
Lane Drager, Consumer Protection Program Coordinator, Boulder County Public Health
Lane received a bachelors in Civil and Environmental Engineering from the University of Illinois at Urbana-Champaign. Lane began his career working for the Illinois Environmental Protection Agency and then the Illinois Department of Public Health. Lane then moved to Colorado and began working for Boulder County Public Health as the environmental health planner. Lane has since moved into the Consumer Protection Program Coordinator role and oversees the food safety, body art, and vector programs. Lane is a graduate of the RIHEL Advanced Leadership Training Program (ALTP) and Boulder County’s Leadership Academy. Lane is currently on the Colorado Environmental Health Associations (CEHA) executive board and serving as Past President. Lane was appointed to the Jefferson County Board of Health in 2015. Lane is on the executive steering committee for the Colorado Public Health Mentoring Program. Lane also collaborates with the Colorado Center for Food Safety and Prevention of Foodborne Disease and the Colorado Integrated Food Safety Center of Excellence.
Lane received a bachelors in Civil and Environmental Engineering from the University of Illinois at Urbana-Champaign. Lane began his career working for the Illinois Environmental Protection Agency and then the Illinois Department of Public Health. Lane then moved to Colorado and began working for Boulder County Public Health as the environmental health planner. Lane has since moved into the Consumer Protection Program Coordinator role and oversees the food safety, body art, and vector programs. Lane is a graduate of the RIHEL Advanced Leadership Training Program (ALTP) and Boulder County’s Leadership Academy. Lane is currently on the Colorado Environmental Health Associations (CEHA) executive board and serving as Past President. Lane was appointed to the Jefferson County Board of Health in 2015. Lane is on the executive steering committee for the Colorado Public Health Mentoring Program. Lane also collaborates with the Colorado Center for Food Safety and Prevention of Foodborne Disease and the Colorado Integrated Food Safety Center of Excellence.
Ted Elkin, Deputy Director for Regulatory Affairs, FDA
Ted Elkin is the FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Deputy Director for Regulatory Affairs. The following CFSAN Offices are assigned to him: Analytics and Outreach, Compliance, Dietary Supplement Programs, Food Safety, Nutrition and Food Labeling, and the International Affairs Staff. Ted joined FDA in August 2009. He has earned post graduate degrees in Environmental Engineering and Public Administration.
Prior to coming to FDA, he worked for the Maryland Department of Health and Mental Hygiene as Chief of Staff to the Deputy Secretary of Public Health. Ted was also the Deputy Director, of the Office of Food Protection and Consumer Health Services: There he was responsible for overseeing a variety of public health regulatory programs including food regulatory programs, and regulatory programs related to product safety.
Ted is an environmental sciences and public health administration expert with over 35 years of experience and extensive organizational, communication, training, administrative and program development skills. He has demonstrated leadership in disseminating knowledge on food protection and security and community services programs to the general public and industry. He has communicated policy and interpretation to members of Congress, Pentagon officials, and other Federal Agencies. Ted has extensive experience in developing, strategic planning and implementation of a variety of public health regulatory programs, including: food regulatory programs; and regulatory programs related to product safety and food defense programs.
Ted Elkin is the FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Deputy Director for Regulatory Affairs. The following CFSAN Offices are assigned to him: Analytics and Outreach, Compliance, Dietary Supplement Programs, Food Safety, Nutrition and Food Labeling, and the International Affairs Staff. Ted joined FDA in August 2009. He has earned post graduate degrees in Environmental Engineering and Public Administration.
Prior to coming to FDA, he worked for the Maryland Department of Health and Mental Hygiene as Chief of Staff to the Deputy Secretary of Public Health. Ted was also the Deputy Director, of the Office of Food Protection and Consumer Health Services: There he was responsible for overseeing a variety of public health regulatory programs including food regulatory programs, and regulatory programs related to product safety.
Ted is an environmental sciences and public health administration expert with over 35 years of experience and extensive organizational, communication, training, administrative and program development skills. He has demonstrated leadership in disseminating knowledge on food protection and security and community services programs to the general public and industry. He has communicated policy and interpretation to members of Congress, Pentagon officials, and other Federal Agencies. Ted has extensive experience in developing, strategic planning and implementation of a variety of public health regulatory programs, including: food regulatory programs; and regulatory programs related to product safety and food defense programs.
Jeanne Garbarino, Principal REHS, Vineland Health Department
Jeanne Garbarino graduated with a Bachelors of Science Degree in Public Health from Richard Stockton College of NJ. Jeanne has worked for the Vineland Health Department ever since. Vineland Health Department enrolled in the FDA’s National Voluntary Standards Program in 2002. Jeanne was given the responsibility of managing that project and supervises 6 inspectors in various programs, including the Retail Food Program. In 2012, the Vineland Health Department completed all 9 standards.
Jeanne Garbarino graduated with a Bachelors of Science Degree in Public Health from Richard Stockton College of NJ. Jeanne has worked for the Vineland Health Department ever since. Vineland Health Department enrolled in the FDA’s National Voluntary Standards Program in 2002. Jeanne was given the responsibility of managing that project and supervises 6 inspectors in various programs, including the Retail Food Program. In 2012, the Vineland Health Department completed all 9 standards.
Scott Gilliam, MBA, CP-FS, Manager, Food Safety Policy & Training, Meijer Corporation
Scott Gilliam is the Food Safety Policy and Training manager at Meijer Corporation. Scott's areas of expertise are auditing, food defense, HACCP, Sanitation, SQF, FDA Food Code Food Safety Training, Pest Control, Seafood HACCP, and Technical Writing
Scott Gilliam is the Food Safety Policy and Training manager at Meijer Corporation. Scott's areas of expertise are auditing, food defense, HACCP, Sanitation, SQF, FDA Food Code Food Safety Training, Pest Control, Seafood HACCP, and Technical Writing
Diane Goyette, Regulatory Counsel,FDA/Office of Regulatory Affairs/Office of Policy and Risk Management
Diane Goyette is a pharmacist and attorney currently serving as a Regulatory Counsel on the Medical Products and Tobacco Policy Staff in ORA’s Office of Policy and Risk Management. Diane began her career with FDA writing regulations in the Center for Drug Evaluation and Research where she wrote Prescription Drug Marketing Act, drug labeling and other regulations. She left the agency for a time, heading up regulatory affairs activities at the Healthcare Distribution Management Association, the trade association representing wholesale drug distributors, and then led a program at the American Pharmacists Association focused on providing 340B Program pharmacy services. Diane returned to FDA in 2012 when she joined the CDER advisory committee staff. She has been on ORA’s medical products policy staff since September 2013, and brings ORA policy perspective to agency discussions, currently focusing on drug compounding and DSCSA implementation.
Diane Goyette is a pharmacist and attorney currently serving as a Regulatory Counsel on the Medical Products and Tobacco Policy Staff in ORA’s Office of Policy and Risk Management. Diane began her career with FDA writing regulations in the Center for Drug Evaluation and Research where she wrote Prescription Drug Marketing Act, drug labeling and other regulations. She left the agency for a time, heading up regulatory affairs activities at the Healthcare Distribution Management Association, the trade association representing wholesale drug distributors, and then led a program at the American Pharmacists Association focused on providing 340B Program pharmacy services. Diane returned to FDA in 2012 when she joined the CDER advisory committee staff. She has been on ORA’s medical products policy staff since September 2013, and brings ORA policy perspective to agency discussions, currently focusing on drug compounding and DSCSA implementation.
Maile Hermida, Associate, Hogan Lovells US LLP
Maile Gradison Hermida is a partner with Hogan Lovells in the area of food law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations.
Maile has experience with a broad range of issues affecting the food industry, including food safety, enforcement, labeling, and claim substantiation. She has particular knowledge about implementation of the FDA Food Safety Modernization Act (FSMA) and helps companies understand their legal obligations under FSMA and develop compliance strategies.
Maile graduated with high honors from The George Washington University Law School, where she served as Executive Editor of The George Washington Law Review, and graduated summa cum laude from Tulane University.
Maile Gradison Hermida is a partner with Hogan Lovells in the area of food law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations.
Maile has experience with a broad range of issues affecting the food industry, including food safety, enforcement, labeling, and claim substantiation. She has particular knowledge about implementation of the FDA Food Safety Modernization Act (FSMA) and helps companies understand their legal obligations under FSMA and develop compliance strategies.
Maile graduated with high honors from The George Washington University Law School, where she served as Executive Editor of The George Washington Law Review, and graduated summa cum laude from Tulane University.
Brenda Holman, Deputy Director, Coordinated Outbreak Response and Evaluation Network, FDA
Brenda Holman has been with FDA twenty eight years. She holds a Bachelor of Science degree in Microbiology and a Master of Science degree in Food Science and Technology. She started with FDA in the Northeast Region as a Milk and Food Program Specialist, then as a Training Officer in State Training Branch in Rockville, Maryland, Assistant Regional Director responsible for State Cooperative Programs in the Pacific Region, District Director in Detroit District, District Director in New York District, Regional Food and Drug Director in the Pacific Region, Executive Director of ORA Strategic Initiatives and most recently as the Deputy Director of CORE in the Office of Foods and Veterinary Medicine. In this capacity she is overseeing the operational aspects of FDA’s Foodborne Outbreak unit responsible for coordination of foodborne illness outbreaks involving FDA regulated Food and feed products and ingredients from first signs of illnesses through response to the illness outbreaks and then oversight of post response findings aimed at prevention of future and/or subsequent outbreaks from the same sources. Her previous work experience includes seven years in state and local health departments in Texas, four years in industry quality assurance and two years as a food industry consultant.
Brenda Holman has been with FDA twenty eight years. She holds a Bachelor of Science degree in Microbiology and a Master of Science degree in Food Science and Technology. She started with FDA in the Northeast Region as a Milk and Food Program Specialist, then as a Training Officer in State Training Branch in Rockville, Maryland, Assistant Regional Director responsible for State Cooperative Programs in the Pacific Region, District Director in Detroit District, District Director in New York District, Regional Food and Drug Director in the Pacific Region, Executive Director of ORA Strategic Initiatives and most recently as the Deputy Director of CORE in the Office of Foods and Veterinary Medicine. In this capacity she is overseeing the operational aspects of FDA’s Foodborne Outbreak unit responsible for coordination of foodborne illness outbreaks involving FDA regulated Food and feed products and ingredients from first signs of illnesses through response to the illness outbreaks and then oversight of post response findings aimed at prevention of future and/or subsequent outbreaks from the same sources. Her previous work experience includes seven years in state and local health departments in Texas, four years in industry quality assurance and two years as a food industry consultant.
Anne E. Johnson, District Director, Philadelphia District Office, FDA
Anne Johnson is the District Director of the U.S. Food and Drug Administration’s Philadelphia District Office. She is responsible for overall executive leadership, guidance and direction in all Agency programs and operations, specifically covering the states of Pennsylvania and Delaware. Ms. Johnson started with the F.D.A in 1990, as an Investigator, inspecting firms in just about every commodity area including food and medical products and becoming a district Biologics Specialist. From there, she joined ORA’s Office of Enforcement as a compliance officer, in 2000, specializing in enforcement and regulatory follow-up matters for the licensed vaccine, plasma fractionator, in vitro diagnostic, therapeutic (biotech) and allergenic industries. Ms. Johnson later returned to Philadelphia, in 2005, and served as a Supervisory Investigator, and the District’s food monitor. From 2011-2016 she was the Deputy District Director, and most recently has been selected as the permanent District Director.
The Philadelphia District office contains a staff complement including investigators, compliance officers and robust communication and outreach programs directly including emergency response, complaints, recalls, information disclosure (FOI), state programs and contracts, and public/media affairs. Operations include regulatory inspections, investigations, and enforcement in domestic, imports and international arenas. Ms. Johnson is active on the speaking circuit, presenting at various conferences, while conducting internal and external training. She is holds a B.A. in Chemistry with a Biochemistry minor, from Rutgers University.
Anne Johnson is the District Director of the U.S. Food and Drug Administration’s Philadelphia District Office. She is responsible for overall executive leadership, guidance and direction in all Agency programs and operations, specifically covering the states of Pennsylvania and Delaware. Ms. Johnson started with the F.D.A in 1990, as an Investigator, inspecting firms in just about every commodity area including food and medical products and becoming a district Biologics Specialist. From there, she joined ORA’s Office of Enforcement as a compliance officer, in 2000, specializing in enforcement and regulatory follow-up matters for the licensed vaccine, plasma fractionator, in vitro diagnostic, therapeutic (biotech) and allergenic industries. Ms. Johnson later returned to Philadelphia, in 2005, and served as a Supervisory Investigator, and the District’s food monitor. From 2011-2016 she was the Deputy District Director, and most recently has been selected as the permanent District Director.
The Philadelphia District office contains a staff complement including investigators, compliance officers and robust communication and outreach programs directly including emergency response, complaints, recalls, information disclosure (FOI), state programs and contracts, and public/media affairs. Operations include regulatory inspections, investigations, and enforcement in domestic, imports and international arenas. Ms. Johnson is active on the speaking circuit, presenting at various conferences, while conducting internal and external training. She is holds a B.A. in Chemistry with a Biochemistry minor, from Rutgers University.
DR. Linda Katz, Director for the Office of Cosmetics and Colors (OCAC). FDA
Dr. Linda Katz has held a variety of positions at the FDA. Since 2002 she has been the Director for the Office of Cosmetics and Colors (OCAC), has served as Chief Medical Officer in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) since 2007, and was the Acting Deputy Director for Operations at CFSAN from September 2012 through March 2013. As Director of OCAC, she establishes the priorities and missions of OCAC, focusing on cosmetic safety, compliance, certification of color additives research, such as nanotechnology, photoxicity and percutaneous absorption. As Chief Medical Officer she addresses safety and medical concerns for CFSAN regulated products. She has received numerous awards. She has also presented on a wide variety of topics in both the U.S and abroad, and has had numerous publications in relevant regulatory areas, including those related to cosmetics, nanotechnology from a cosmetic and food perspective, and drug related issues. Prior to assuming leadership of OCAC, she began her FDA career in the Center for Drug Evaluation and Research (CDER), in 1989, holding positions of Deputy Director for the Division of Over-the-Counter Drug Products, Deputy Director for the Division of Dermatologic and Dental Drug Products, and Team Leader and Acting Director for the Pilot Drug Evaluation Staff. Dr. Katz received her B.A., magna cum laude, in biology from the University of Pennsylvania, a M.P.H. in epidemiology and health planning from the University of Michigan, and her M.D. from the University of Connecticut. She completed her internship and residency in Internal Medicine, and fellowship in Rheumatology, at the George Washington University Medical Center, in Washington, D.C. She is a Fellow in the American College of Physicians, a Fellow Member of the American College of Rheumatology, and is boarded in Internal Medicine with a subspecialty in Rheumatology. In addition, Dr. Katz maintains an academic appointment, as Associate Clinical Professor of Medicine, at The Uniformed Services University of the Health Sciences. In her latter position she continues to teach.
Dr. Linda Katz has held a variety of positions at the FDA. Since 2002 she has been the Director for the Office of Cosmetics and Colors (OCAC), has served as Chief Medical Officer in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) since 2007, and was the Acting Deputy Director for Operations at CFSAN from September 2012 through March 2013. As Director of OCAC, she establishes the priorities and missions of OCAC, focusing on cosmetic safety, compliance, certification of color additives research, such as nanotechnology, photoxicity and percutaneous absorption. As Chief Medical Officer she addresses safety and medical concerns for CFSAN regulated products. She has received numerous awards. She has also presented on a wide variety of topics in both the U.S and abroad, and has had numerous publications in relevant regulatory areas, including those related to cosmetics, nanotechnology from a cosmetic and food perspective, and drug related issues. Prior to assuming leadership of OCAC, she began her FDA career in the Center for Drug Evaluation and Research (CDER), in 1989, holding positions of Deputy Director for the Division of Over-the-Counter Drug Products, Deputy Director for the Division of Dermatologic and Dental Drug Products, and Team Leader and Acting Director for the Pilot Drug Evaluation Staff. Dr. Katz received her B.A., magna cum laude, in biology from the University of Pennsylvania, a M.P.H. in epidemiology and health planning from the University of Michigan, and her M.D. from the University of Connecticut. She completed her internship and residency in Internal Medicine, and fellowship in Rheumatology, at the George Washington University Medical Center, in Washington, D.C. She is a Fellow in the American College of Physicians, a Fellow Member of the American College of Rheumatology, and is boarded in Internal Medicine with a subspecialty in Rheumatology. In addition, Dr. Katz maintains an academic appointment, as Associate Clinical Professor of Medicine, at The Uniformed Services University of the Health Sciences. In her latter position she continues to teach.
Valerie Knox, Quality Systems Manager, FDA
Valerie Knox assumed the duties of Quality Systems Manager for the FDA’s Arkansas Regional Laboratory in 2013. She is a Certified Manager of Quality/Organizational Excellence (CMQ/OE) and
Certified Quality Auditor (CQA), American Society for Quality (ASQ) with over twenty-five years’ experience working in laboratories and Quality Assurance/Control. She has been a Medical
Technologist with William Beaumont Army Medical Center at Fort Bliss TX, Deputy Quality Manager for Department of Laboratory Sciences at U.S. Army Health Command – Europe Region in
Landstuhl, Germany, and a Quality Assurance Specialist with the FBI Laboratory in Quantico, VA. prior to coming to ARL.
Valerie Knox assumed the duties of Quality Systems Manager for the FDA’s Arkansas Regional Laboratory in 2013. She is a Certified Manager of Quality/Organizational Excellence (CMQ/OE) and
Certified Quality Auditor (CQA), American Society for Quality (ASQ) with over twenty-five years’ experience working in laboratories and Quality Assurance/Control. She has been a Medical
Technologist with William Beaumont Army Medical Center at Fort Bliss TX, Deputy Quality Manager for Department of Laboratory Sciences at U.S. Army Health Command – Europe Region in
Landstuhl, Germany, and a Quality Assurance Specialist with the FBI Laboratory in Quantico, VA. prior to coming to ARL.
Scott Krause, Retail Food Specialist, FDA
“I am a Retail Food Specialist for FDA's Southwest Region. I provide investigational, inspectional, technical, and consultative assistance on Retail Food Program issues. I serve as a technical authority on the Food Code. I recommend to state and local health official’s new enforcement approaches. I conduct on-site inspections & surveys to evaluate sanitary conditions in the industry and to evaluate the effectiveness of state and local programs. I certify State Food Service Officers and I conduct various seminars or training courses on Retail Food Protection Program areas. I also have 6 years of import experience both working in the field and at FDA’s Prior Notice Center (PNC). I have a Bachelors degree in Biochemistry and a Masters degree in Food Science.”
“I am a Retail Food Specialist for FDA's Southwest Region. I provide investigational, inspectional, technical, and consultative assistance on Retail Food Program issues. I serve as a technical authority on the Food Code. I recommend to state and local health official’s new enforcement approaches. I conduct on-site inspections & surveys to evaluate sanitary conditions in the industry and to evaluate the effectiveness of state and local programs. I certify State Food Service Officers and I conduct various seminars or training courses on Retail Food Protection Program areas. I also have 6 years of import experience both working in the field and at FDA’s Prior Notice Center (PNC). I have a Bachelors degree in Biochemistry and a Masters degree in Food Science.”
Steven Mandernach, Bureau Chief, Iowa Department of Inspections and Appeals Food and Consumer Safety Bureau
Steven Mandernach (Mawn-dur-knock) is the Bureau Chief for the Iowa Department of Inspections and Appeals Food and Consumer Safety Bureau. Mandernach is currently President-elect of the Association of Food and Drug Officials and co-chair of the Association’s Laws and Regulations committee. He has also served as the chair for the Manufactured Food Regulatory Program Alliance.
Mandernach has a Juris Doctorate from Drake University Law School. He is currently pursuing a Master’s of Science in Food Safety from Michigan State University
Steven Mandernach (Mawn-dur-knock) is the Bureau Chief for the Iowa Department of Inspections and Appeals Food and Consumer Safety Bureau. Mandernach is currently President-elect of the Association of Food and Drug Officials and co-chair of the Association’s Laws and Regulations committee. He has also served as the chair for the Manufactured Food Regulatory Program Alliance.
Mandernach has a Juris Doctorate from Drake University Law School. He is currently pursuing a Master’s of Science in Food Safety from Michigan State University
Carl A Mayes, USDA
Mr. Carl A. Mayes is currently the Assistant Administrator (AA) for the Office of Investigation, Enforcement and Audit (OIEA) in the Food Safety and Inspection Service (FSIS) at the United States Department of Agriculture (USDA). He leads the Agency’s surveillance and investigation activities for incidents of foodborne illness outbreaks, recalls, natural disasters and intentional contamination. Mr. Mayes also oversees state and foreign audit programs and enforcement and litigation functions for FSIS. Prior to joining FSIS, Mr. Mayes worked for the Defense Intelligence Agency (DIA), serving as the Mission Application Division Chief for Counterintelligence (CI) and Human Intelligence (HUMINT) software applications. Previously, Mr. Mayes spent 21 years in the United States Air Force (USAF), where the majority of his time was spent with the Security Forces and supporting Command, Control, Communications, Computers, Intelligence, Surveillance and Reconnaissance (C4ISR) activities.
Mr. Carl A. Mayes is currently the Assistant Administrator (AA) for the Office of Investigation, Enforcement and Audit (OIEA) in the Food Safety and Inspection Service (FSIS) at the United States Department of Agriculture (USDA). He leads the Agency’s surveillance and investigation activities for incidents of foodborne illness outbreaks, recalls, natural disasters and intentional contamination. Mr. Mayes also oversees state and foreign audit programs and enforcement and litigation functions for FSIS. Prior to joining FSIS, Mr. Mayes worked for the Defense Intelligence Agency (DIA), serving as the Mission Application Division Chief for Counterintelligence (CI) and Human Intelligence (HUMINT) software applications. Previously, Mr. Mayes spent 21 years in the United States Air Force (USAF), where the majority of his time was spent with the Security Forces and supporting Command, Control, Communications, Computers, Intelligence, Surveillance and Reconnaissance (C4ISR) activities.
Dr. Kelly A. McBride, Assistant Professor of Communication and Public Relations, York College of PA
Dr. Kelly A. McBride is an Assistant Professor of Communication and Public Relations for York College of Pennsylvania where she serves as advisor to the Lambda Pi Eta National Communication Honor Society, and the Public Relations Student Society of America. She is also an assistant advisor to the Alpha Sigma Tau sorority where she is an alumni member. Prior to York College, she was a Visiting Assistant Professor at Virginia Tech where she taught media and public relation courses as well as international communication at the Steger Center for International Scholarship in Riva San Vitale, Switzerland. While at Tech, she served as the advisor for the Lambda Pi Eta National Communication Association Honor Society as well as the PRSSA Bateman Team Competition. Dr. McBride was also a Visiting Assistant Professor at La Salle University in Philadelphia, PA.
A member of the National Communication Association and the Public Relations Society of America, Dr. McBride has a 20-year career in the field of public relations. She was the Press Secretary and Director of Communications for former Pennsylvania Lieutenant Governor Mark S. Singel, and held various positions in communications in both for and non-profit organizations. Her final position in the field was as a Director of Communications for a Pennsylvania public school district.
Dr. McBride holds a doctorate from Immaculata University in Malvern, PA; a master’s degree from Alvernia University in Reading, PA; and a B.S. in Business Management from Lock Haven University of Pennsylvania. Her primary research interest is social media, including the world of reality television.
Dr. Kelly A. McBride is an Assistant Professor of Communication and Public Relations for York College of Pennsylvania where she serves as advisor to the Lambda Pi Eta National Communication Honor Society, and the Public Relations Student Society of America. She is also an assistant advisor to the Alpha Sigma Tau sorority where she is an alumni member. Prior to York College, she was a Visiting Assistant Professor at Virginia Tech where she taught media and public relation courses as well as international communication at the Steger Center for International Scholarship in Riva San Vitale, Switzerland. While at Tech, she served as the advisor for the Lambda Pi Eta National Communication Association Honor Society as well as the PRSSA Bateman Team Competition. Dr. McBride was also a Visiting Assistant Professor at La Salle University in Philadelphia, PA.
A member of the National Communication Association and the Public Relations Society of America, Dr. McBride has a 20-year career in the field of public relations. She was the Press Secretary and Director of Communications for former Pennsylvania Lieutenant Governor Mark S. Singel, and held various positions in communications in both for and non-profit organizations. Her final position in the field was as a Director of Communications for a Pennsylvania public school district.
Dr. McBride holds a doctorate from Immaculata University in Malvern, PA; a master’s degree from Alvernia University in Reading, PA; and a B.S. in Business Management from Lock Haven University of Pennsylvania. Her primary research interest is social media, including the world of reality television.
Julie Melia, Michigan Department of Agriculture & Rural Development, Food Safety Inspector and Standardized Shellfish Inspector
Julie Melia is a Food Safety Inspector for the Michigan Department of Agriculture and Rural Development in the West Region. She is the Standardized Shellfish Inspector for the State of Michigan. She is a member of AFDO and NCAFDO. Julie has served on several committees for the Michigan Environmental Health Association including AEC Program Coordinator in March 2004 and Journal Editor. She was also Past President of the Southwest Environmental Health Association (SWMEHA). Previously, Julie was employed as a Food Sanitarian for the Kent County Health Department in Grand Rapids, Michigan and was a Standardized Trainer.
Julie Melia is a Food Safety Inspector for the Michigan Department of Agriculture and Rural Development in the West Region. She is the Standardized Shellfish Inspector for the State of Michigan. She is a member of AFDO and NCAFDO. Julie has served on several committees for the Michigan Environmental Health Association including AEC Program Coordinator in March 2004 and Journal Editor. She was also Past President of the Southwest Environmental Health Association (SWMEHA). Previously, Julie was employed as a Food Sanitarian for the Kent County Health Department in Grand Rapids, Michigan and was a Standardized Trainer.
Steve Moris, Program Manager, Division of Food Safety and Lodging, Kansas Department of Agriculture
Steve Moris is the Program Manager for the Division of Food Safety and Lodging at the Kansas Department of Agriculture. He has been with the program since 2006. The Food Safety Division is responsible for licensing and inspecting over 16,000 food establishments, food manufacturers, food storage, and lodging facilities. The program has 49 field staff and 10 office staff. Steve has helped the Program grow to almost ten times its size since he started in 2006. Prior to his work at the Department of Agriculture he spent 16 years working for the Kroger Company in positions ranging from the front-end clerk to store manager. In addition, to the work Steve does to protect public safety in the state of Kansas he serves on numerous AFDO, CFP, and PFP committees. He is the past President and current director at large for the MCAFDO board. Steve is currently the Secretary/Treasurer for the AFDO Executive Board. Steve and his wife Holly have two wonderful sons, Blake who is a civil engineering major at Kansas State University and Evan who is a freshman at Manhattan high school. In his free time he enjoys attending Kansas State University sporting events, refurbishing furniture, and is involved in Evan’s rowing club by being on the Manhattan Junior Crew and the Kansas State Rowing Association boards.
Steve Moris is the Program Manager for the Division of Food Safety and Lodging at the Kansas Department of Agriculture. He has been with the program since 2006. The Food Safety Division is responsible for licensing and inspecting over 16,000 food establishments, food manufacturers, food storage, and lodging facilities. The program has 49 field staff and 10 office staff. Steve has helped the Program grow to almost ten times its size since he started in 2006. Prior to his work at the Department of Agriculture he spent 16 years working for the Kroger Company in positions ranging from the front-end clerk to store manager. In addition, to the work Steve does to protect public safety in the state of Kansas he serves on numerous AFDO, CFP, and PFP committees. He is the past President and current director at large for the MCAFDO board. Steve is currently the Secretary/Treasurer for the AFDO Executive Board. Steve and his wife Holly have two wonderful sons, Blake who is a civil engineering major at Kansas State University and Evan who is a freshman at Manhattan high school. In his free time he enjoys attending Kansas State University sporting events, refurbishing furniture, and is involved in Evan’s rowing club by being on the Manhattan Junior Crew and the Kansas State Rowing Association boards.
Dr. Stephen Ostroff, Acting Commissioner, FDA
Dr. Stephen Ostroff, M.D., served as FDA's Acting Commissioner until February 2016.
Previously, he was FDA’s Chief Scientist, where he was responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives.
Dr. Ostroff joined FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to FDA’s Office of Foods and Veterinary Medicine.
Prior to that, he served as Deputy Director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General).
Dr. Ostroff was the Director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania and has consulted for the World Bank on public health projects in South Asia and Latin America.
Dr. Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at CDC.
He is a fellow of the Infectious Disease Society of America and the American College of Physicians, and prior to assuming the role of FDA’s Acting Commissioner, he chaired the Public Health Committee of the American Society for Microbiology’s Public and Scientific Affairs Board.
Dr. Stephen Ostroff, M.D., served as FDA's Acting Commissioner until February 2016.
Previously, he was FDA’s Chief Scientist, where he was responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives.
Dr. Ostroff joined FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to FDA’s Office of Foods and Veterinary Medicine.
Prior to that, he served as Deputy Director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General).
Dr. Ostroff was the Director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania and has consulted for the World Bank on public health projects in South Asia and Latin America.
Dr. Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at CDC.
He is a fellow of the Infectious Disease Society of America and the American College of Physicians, and prior to assuming the role of FDA’s Acting Commissioner, he chaired the Public Health Committee of the American Society for Microbiology’s Public and Scientific Affairs Board.
Marla A. Phillips, Ph.D. Director, Xavier Health. Xavier University
Marla A. Phillips, Ph.D. Director, Xavier Health. Xavier University. Marla joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 as a Senior Project Chemist in the Analytical Methods Development group, became Manager of the Quality Control Laboratory for the Philadelphia plant site, and ultimately served as the Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.
Marla A. Phillips, Ph.D. Director, Xavier Health. Xavier University. Marla joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 as a Senior Project Chemist in the Analytical Methods Development group, became Manager of the Quality Control Laboratory for the Philadelphia plant site, and ultimately served as the Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.
Andre Pierce, Director of Environmental Health and Safety Division
Andre Pierce is the Director of Environmental Health and Safety Division in Wake County, North Carolina. He began his public health career in 1987 and has worked in a number of areas of environmental health. He became the director of the Division in 2007 and enrolled the program in the FDA Program Standards in 2008. Since that time, Wake County has worked actively on the Program Standards and now claims six of them. Wake County completed its second risk factor study in 2015, which showed improvement in a number of risk factors, due in large part to the adoption of the FDA Food Code in 2012. Wake County has participated in three cohorts of the NACCHO Mentorship Program, and has received grant funding through AFDO to support its quality assurance initiatives.
Andre Pierce is the Director of Environmental Health and Safety Division in Wake County, North Carolina. He began his public health career in 1987 and has worked in a number of areas of environmental health. He became the director of the Division in 2007 and enrolled the program in the FDA Program Standards in 2008. Since that time, Wake County has worked actively on the Program Standards and now claims six of them. Wake County completed its second risk factor study in 2015, which showed improvement in a number of risk factors, due in large part to the adoption of the FDA Food Code in 2012. Wake County has participated in three cohorts of the NACCHO Mentorship Program, and has received grant funding through AFDO to support its quality assurance initiatives.
Chris Rose, Director of Operations, Office of Medical Cannabis, Health Canada
Chris Rose is currently the Director of Operations within the Office of Medical Cannabis at Health Canada Chris’ career has also included operational leadership positions in the Health Products and Food Branch of Health Canada, as well as in private industry and at the provincial healthcare level. Chris has a master’s degree in Applied Science in Biomedical Engineering from Dalhousie University and a Bachelor of Science from St. Mary’s University.
Chris Rose is currently the Director of Operations within the Office of Medical Cannabis at Health Canada Chris’ career has also included operational leadership positions in the Health Products and Food Branch of Health Canada, as well as in private industry and at the provincial healthcare level. Chris has a master’s degree in Applied Science in Biomedical Engineering from Dalhousie University and a Bachelor of Science from St. Mary’s University.
Pete Salsbury, Project manager, CFSAN
Pete Salsbury is a project manager in the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Retail Food Protection Staff. His projects include working with the Partnership for Food Protection (PFP), food safety partnership projects with the Restaurant and Retail Food Store industries, and retail food projects with NACCHO and AFDO. He previously served in FDA as the Acting Special Assistant to the Director, Division of Federal-State Relations in ORA, Special Assistant to CFSAN’s Deputy Director for Regulatory Affairs, Acting Director of CFSAN's Executive Operation Staff and as a science policy analyst and biologist.
Pete Salsbury is a project manager in the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Retail Food Protection Staff. His projects include working with the Partnership for Food Protection (PFP), food safety partnership projects with the Restaurant and Retail Food Store industries, and retail food projects with NACCHO and AFDO. He previously served in FDA as the Acting Special Assistant to the Director, Division of Federal-State Relations in ORA, Special Assistant to CFSAN’s Deputy Director for Regulatory Affairs, Acting Director of CFSAN's Executive Operation Staff and as a science policy analyst and biologist.
Erin Sawyer, President, CASA; Director of Field Operations, NYS Department of Agriculture and Markets
Erin is the current President for the Central Atlantic States Association of Food and Drug Officials (CASA) and has worked for the NYS Department of Agriculture and Markets for over sixteen years in various Food Inspector titles. After earning her bachelor’s degree in biology from Russell Sage College in Troy, NY, Erin began her career as a Food Inspector trainee conducting inspections at retail food stores and various manufactured food facilities in 2000. She transferred into the central office in 2003, and in 2005, was promoted to a supervising food inspector position. In 2009, Erin accepted a promotion to the Director of Field Operations where she oversees a field staff of 100 inspectors and activities they conduct. She is involved with implementing the requirements associated with the MFRPS and RRT grants. Erin has served on the NENY CASA board since 2003, serving as NENY CASA President before being elected to the position of National Board Representative in 2009 and becoming CASA President in 2016.
Erin is the current President for the Central Atlantic States Association of Food and Drug Officials (CASA) and has worked for the NYS Department of Agriculture and Markets for over sixteen years in various Food Inspector titles. After earning her bachelor’s degree in biology from Russell Sage College in Troy, NY, Erin began her career as a Food Inspector trainee conducting inspections at retail food stores and various manufactured food facilities in 2000. She transferred into the central office in 2003, and in 2005, was promoted to a supervising food inspector position. In 2009, Erin accepted a promotion to the Director of Field Operations where she oversees a field staff of 100 inspectors and activities they conduct. She is involved with implementing the requirements associated with the MFRPS and RRT grants. Erin has served on the NENY CASA board since 2003, serving as NENY CASA President before being elected to the position of National Board Representative in 2009 and becoming CASA President in 2016.
Matt Schiering, Vice President & General Manager, Sani Professional
Mr. Schiering leads the food safety division of PDI, Inc., one of the leading infection prevention companies in the world. He has held this position for six years, during which he has dramatically grown the size and scope of the enterprise. A few of the world-class customers with whom he has built strong relationships include Starbucks®, Chick-fil-A®, P.F. Chang’s China Bistro® & TGIFridays®.
Schiering holds a B.S. from the prestigious Cornell University School of Hotel Administration and an M.B.A. from University of Texas (El Paso). His experience leading sales, marketing and product development teams spans more than 20 years at consumer and professional products companies including Johnson & Johnson, SCA Hygiene & Irving Personal Care. His track record of growing brands through strategic alliances, innovative positioning and new product development is well documented and he has been published several times in Brandweek® Magazine.
Schiering was recently awarded a patent in support of a food safety invention which is currently in use at over 10,000 foodservice operations. He is ServSafe® certified and insists that every member of his team earns this designation. He is also a decorated veteran of the United States Army, having served 1990 – 1994.
He volunteers regularly for Meals on Wheels® of Rockland County, NY, where he resides with his family.
Mr. Schiering leads the food safety division of PDI, Inc., one of the leading infection prevention companies in the world. He has held this position for six years, during which he has dramatically grown the size and scope of the enterprise. A few of the world-class customers with whom he has built strong relationships include Starbucks®, Chick-fil-A®, P.F. Chang’s China Bistro® & TGIFridays®.
Schiering holds a B.S. from the prestigious Cornell University School of Hotel Administration and an M.B.A. from University of Texas (El Paso). His experience leading sales, marketing and product development teams spans more than 20 years at consumer and professional products companies including Johnson & Johnson, SCA Hygiene & Irving Personal Care. His track record of growing brands through strategic alliances, innovative positioning and new product development is well documented and he has been published several times in Brandweek® Magazine.
Schiering was recently awarded a patent in support of a food safety invention which is currently in use at over 10,000 foodservice operations. He is ServSafe® certified and insists that every member of his team earns this designation. He is also a decorated veteran of the United States Army, having served 1990 – 1994.
He volunteers regularly for Meals on Wheels® of Rockland County, NY, where he resides with his family.
David Schmitt, DVM,State Veterinarian and Chief, IOWA DEPARTMENT OF AGRICULTURE & LAND STEWARDSHIP
Dr. Schmitt graduated from Iowa State University College of Veterinary Medicine in 1973. After one year of private practice in Roseville, Minnesota, Dr. Schmitt moved to Stuart, Iowa, in 1974 and practiced veterinary medicine in a group mixed animal practice there until 1999. He began his duties in the Iowa Department of Agriculture and Land Stewardship as the Assistant State Veterinarian in 1999 and was appointed State Veterinarian in 2008.
Dr. Schmitt graduated from Iowa State University College of Veterinary Medicine in 1973. After one year of private practice in Roseville, Minnesota, Dr. Schmitt moved to Stuart, Iowa, in 1974 and practiced veterinary medicine in a group mixed animal practice there until 1999. He began his duties in the Iowa Department of Agriculture and Land Stewardship as the Assistant State Veterinarian in 1999 and was appointed State Veterinarian in 2008.
Pieter A. Sheehan, Director, Division of Environmental Health, Department of Health in Fairfax, Virginia
Pieter A. Sheehan is the Director of the Division of Environmental Health with the Fairfax County, Department of Health in Fairfax, Virginia. Fairfax County is a suburban county in Virginia of approximately 1.3 million people. Mr. Sheehan joined Fairfax County in April 2012. He currently is tasked with overseeing the development of work and operational standards for the Division of Environmental Health, one of four divisions of the department. The division consists of the regulatory activities concerning: Food Safety, Lodging, Childcare, Body Art, Recreational Aquatic, Tobacco/Indoor Air, Drinking Water and Onsite Sewage. Prior to Fairfax County Mr. Sheehan was with St. Charles County Department of Community Health and the Environment in St. Charles, Missouri; St. Louis County Department of Health in Clayton, Missouri; Monterey County, Department of Health in Salinas, California; and Maricopa County, Department of Environmental Services in Phoenix, Arizona.
Pieter A. Sheehan is the Director of the Division of Environmental Health with the Fairfax County, Department of Health in Fairfax, Virginia. Fairfax County is a suburban county in Virginia of approximately 1.3 million people. Mr. Sheehan joined Fairfax County in April 2012. He currently is tasked with overseeing the development of work and operational standards for the Division of Environmental Health, one of four divisions of the department. The division consists of the regulatory activities concerning: Food Safety, Lodging, Childcare, Body Art, Recreational Aquatic, Tobacco/Indoor Air, Drinking Water and Onsite Sewage. Prior to Fairfax County Mr. Sheehan was with St. Charles County Department of Community Health and the Environment in St. Charles, Missouri; St. Louis County Department of Health in Clayton, Missouri; Monterey County, Department of Health in Salinas, California; and Maricopa County, Department of Environmental Services in Phoenix, Arizona.
Mark Speltz, Chief Inspector, Iowa Department of Inspections and Appeals Food and Consumer Safety Bureau
Mark received a BS in Hotel Restaurant and Institutional Management from Iowa State University in 1994. He spent the next 6 years managing food service operations in Arizona, Maryland, and Iowa. Mark worked for 10 years as a field inspector then 5 years as the Training Specialist and Retail Food Program Lead for the Department.Currently he serves as the Chief Inspector for the Department and oversees field operations; Local Contracting Heath Departments, data system initiatives, and Retail Program Standards.
Mark received a BS in Hotel Restaurant and Institutional Management from Iowa State University in 1994. He spent the next 6 years managing food service operations in Arizona, Maryland, and Iowa. Mark worked for 10 years as a field inspector then 5 years as the Training Specialist and Retail Food Program Lead for the Department.Currently he serves as the Chief Inspector for the Department and oversees field operations; Local Contracting Heath Departments, data system initiatives, and Retail Program Standards.
Douglas Stearn, Director, Office of Enforcement and Import Operations, FDA
Douglas Stearn is currently the director of the Office of Enforcement and Import Operations. The office is comprised of the Division of Import Operations, the Division of Enforcement, and the Division of Compliance Systems, which are the ORA headquarters units responsible for coordinating activities related to imports, compliance, recalls, and data systems. Mr. Stearn began this position in December 2013 after spending almost four years as the assistant director and then the deputy director of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. Prior to joining CDER, Mr. Stearn was the director of the Division of Compliance Policy in the Office of Enforcement for almost two years. Mr. Stearn received his undergraduate degree from Brown University in 1987. He received his law degree in 1991 from Cornell Law School. Immediately before joining FDA, Mr. Stearn worked as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for over fifteen years. In the course of his work at the Department of Justice, Mr. Stearn litigated numerous civil and criminal cases referred by FDA and other consumer protection agencies.
Douglas Stearn is currently the director of the Office of Enforcement and Import Operations. The office is comprised of the Division of Import Operations, the Division of Enforcement, and the Division of Compliance Systems, which are the ORA headquarters units responsible for coordinating activities related to imports, compliance, recalls, and data systems. Mr. Stearn began this position in December 2013 after spending almost four years as the assistant director and then the deputy director of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. Prior to joining CDER, Mr. Stearn was the director of the Division of Compliance Policy in the Office of Enforcement for almost two years. Mr. Stearn received his undergraduate degree from Brown University in 1987. He received his law degree in 1991 from Cornell Law School. Immediately before joining FDA, Mr. Stearn worked as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for over fifteen years. In the course of his work at the Department of Justice, Mr. Stearn litigated numerous civil and criminal cases referred by FDA and other consumer protection agencies.
Dr. Eric Stevens, FDA
Dr. Eric Stevens is an FDA Commissioner’s Fellow working at the Center for Food Safety and Applied Nutrition in the Division of Microbiology. He received his Bachelor of Science degree in Biotechnology from Rochester Institute of Technology in 2008 and his Ph.D. in Human Genetics and Molecular Biology from Johns Hopkins School of Medicine in 2013. His thesis focused on using genotype data to infer genetic relationships and reconstruct human pedigrees. From 2013 to 2014 he was a Postdoctoral Fellow at Johns Hopkins and analyzed RNA sequence data in the context of finding differentially expressed genes in schizophrenic individuals compared to controls. He joined FDA/CFSAN in 2014 working to improve both internal and external communication surrounding WGS and its application to outbreak analysis and detection while gaining regulatory experience.
Dr. Eric Stevens is an FDA Commissioner’s Fellow working at the Center for Food Safety and Applied Nutrition in the Division of Microbiology. He received his Bachelor of Science degree in Biotechnology from Rochester Institute of Technology in 2008 and his Ph.D. in Human Genetics and Molecular Biology from Johns Hopkins School of Medicine in 2013. His thesis focused on using genotype data to infer genetic relationships and reconstruct human pedigrees. From 2013 to 2014 he was a Postdoctoral Fellow at Johns Hopkins and analyzed RNA sequence data in the context of finding differentially expressed genes in schizophrenic individuals compared to controls. He joined FDA/CFSAN in 2014 working to improve both internal and external communication surrounding WGS and its application to outbreak analysis and detection while gaining regulatory experience.
Warren Stone, Senior Director of Science Policy, Grocery Manufacturers Association (GMA)
Based in Northern California, Warren Stone is Senior Director of Science Policy, Compliance & Inspection in GMA’s Science Policy division. In this position he works with a broad audience including member and potential member companies, GMA scientific and technical staff, regulatory agents and universities. Warren provides GMA members with training, technical guidance, advice and assistance in areas of food safety, food microbiology, HACCP, food defense, allergen control, regulatory compliance, and sanitation systems. He is an instructor for GMA’s various HACCP course offerings, the new Preventive Controls Qualified Individual courses, Food Defense Workshops, and Better Process Control School. He serves as staff liaison for GMA’s Food Defense Committee, and Sanitation Share Group. Warren also speaks Spanish.
Warren’s background includes 30 years of in-plant experience in both manufacturing and quality assurance in a variety of operations, including low-acid canned foods, frozen foods, meat and poultry, seafood, juice, dairy items, salsas, dips and spreads. He has written numerous HACCP, quality system, sanitation and microbiological control programs for various food companies. He holds both a Master's in Business Administration (MBA) from Canisius College of Buffalo, NY and a Bachelor of Science from the University of California at Davis.
Based in Northern California, Warren Stone is Senior Director of Science Policy, Compliance & Inspection in GMA’s Science Policy division. In this position he works with a broad audience including member and potential member companies, GMA scientific and technical staff, regulatory agents and universities. Warren provides GMA members with training, technical guidance, advice and assistance in areas of food safety, food microbiology, HACCP, food defense, allergen control, regulatory compliance, and sanitation systems. He is an instructor for GMA’s various HACCP course offerings, the new Preventive Controls Qualified Individual courses, Food Defense Workshops, and Better Process Control School. He serves as staff liaison for GMA’s Food Defense Committee, and Sanitation Share Group. Warren also speaks Spanish.
Warren’s background includes 30 years of in-plant experience in both manufacturing and quality assurance in a variety of operations, including low-acid canned foods, frozen foods, meat and poultry, seafood, juice, dairy items, salsas, dips and spreads. He has written numerous HACCP, quality system, sanitation and microbiological control programs for various food companies. He holds both a Master's in Business Administration (MBA) from Canisius College of Buffalo, NY and a Bachelor of Science from the University of California at Davis.
Dr. Lauren Turner, Division of Consolidated Laboratory Services
Dr. Lauren Turner is the Foodborne and Advanced Pathogen Characterization Lead Scientist with the State Laboratory of Virginia, the Division of Consolidated Laboratory Services. Dr. Turner came to DCLS in 2010 as an Association of Public Health Laboratories Emerging Infectious Diseases Research Fellow. She later served in several capacities within the Epidemiologic Support Group at DCLS, as a technical supervisor for the DCLS PulseNet Laboratory, and overseeing method validation and implementation in Food Microbiology, Water Microbiology and Molecular Subtyping Lab Sections. In her current role, Lauren provides technical guidance and analytical support to DCLS laboratories testing clinical, food and environmental samples for pathogens; as well as pathogen subtyping by pulsed-field gel electrophoresis and whole genome sequencing. Dr. Turner coordinates resources and provides programmatic direction in support of federal whole genome sequencing initiatives, including the FDA CFSAN GenomeTrakr Network and CDC Advanced Molecular Detection.
Dr. Lauren Turner is the Foodborne and Advanced Pathogen Characterization Lead Scientist with the State Laboratory of Virginia, the Division of Consolidated Laboratory Services. Dr. Turner came to DCLS in 2010 as an Association of Public Health Laboratories Emerging Infectious Diseases Research Fellow. She later served in several capacities within the Epidemiologic Support Group at DCLS, as a technical supervisor for the DCLS PulseNet Laboratory, and overseeing method validation and implementation in Food Microbiology, Water Microbiology and Molecular Subtyping Lab Sections. In her current role, Lauren provides technical guidance and analytical support to DCLS laboratories testing clinical, food and environmental samples for pathogens; as well as pathogen subtyping by pulsed-field gel electrophoresis and whole genome sequencing. Dr. Turner coordinates resources and provides programmatic direction in support of federal whole genome sequencing initiatives, including the FDA CFSAN GenomeTrakr Network and CDC Advanced Molecular Detection.
Jan Welch, Director Medical Device/RH Program, Office of Regulatory Affairs, FDA
Jan is a proven public health champion with 30+ years’ experience in protecting and improving patient health in both public service and the private sector.
She is a seasoned regulatory expert with medical device and biologic product expertise. Jan is the Director of the Medical Device and Radiological Health Program in FDA’s Office of Regulatory Affairs (ORA). In this position Jan is leading the organizational change for medical devices and rad health to a commodity-based program emphasizing specialization and vertical integration of regulatory processes. Before joining FDA Jan worked for the American Red Cross, the National Institutes of Health, and Vanderbilt University Medical Center.
Jan is a proven public health champion with 30+ years’ experience in protecting and improving patient health in both public service and the private sector.
She is a seasoned regulatory expert with medical device and biologic product expertise. Jan is the Director of the Medical Device and Radiological Health Program in FDA’s Office of Regulatory Affairs (ORA). In this position Jan is leading the organizational change for medical devices and rad health to a commodity-based program emphasizing specialization and vertical integration of regulatory processes. Before joining FDA Jan worked for the American Red Cross, the National Institutes of Health, and Vanderbilt University Medical Center.
Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, Office of Compliance, CDRH/FDA
Marc-Henri Winter is Assessment Program Manager for the Medical Device Single Audit Program. He is a biomedical engineer and has been working since 1998 as assessor of medical devices and auditor of quality management system according to international medical device regulations, including in particular the European and Canadian and US regulations. He joined the U.S. Food and Drug Administration in 2012 to support the development and the implementation of the Medical Device Single Audit Program, a cooperative program initiated by the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), Health Canada, and the US FDA, and based on the foundations established by the International Medical Device Regulatory Forum (IMDRF).
Marc-Henri Winter is Assessment Program Manager for the Medical Device Single Audit Program. He is a biomedical engineer and has been working since 1998 as assessor of medical devices and auditor of quality management system according to international medical device regulations, including in particular the European and Canadian and US regulations. He joined the U.S. Food and Drug Administration in 2012 to support the development and the implementation of the Medical Device Single Audit Program, a cooperative program initiated by the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), Health Canada, and the US FDA, and based on the foundations established by the International Medical Device Regulatory Forum (IMDRF).
John Young, Young & Associates, AFDO Endowment Foundation
John Young is a Partner with Young and Associates, Stowe, Vermont, providing legal and regulatory counseling and consulting in matters involving foods, drugs and dietary supplements. Immediately prior to forming the firm, Mr. Young was Director of Regulatory Affairs-Nutritionals, for the McNeil Consumer Healthcare Company where he was responsible for the development and implementation of U.S., EU and Pacific Rim legal strategies for the establishment and maintenance of functional food and dietary supplement businesses.
Mr. Young began his career as a Trial Attorney for the Food and Drug Division of the then Department of Health, Education and Welfare in Washington DC, becoming Chief of the Litigation Branch of the Division. Following the government, he joined the Thomas J. Lipton Company as Assistant General Counsel where he was responsible for a wide variety of corporate legal matters including FDA, USDA, and FTC issues. He is a graduate of Middlebury College in Vermont, and the New York University School of Law. He has been active in AFDO for more than 30 years, a member of a number of committees, and currently Chairman of the Board of Trustees of the AFDO Endowment Foundation.
John Young is a Partner with Young and Associates, Stowe, Vermont, providing legal and regulatory counseling and consulting in matters involving foods, drugs and dietary supplements. Immediately prior to forming the firm, Mr. Young was Director of Regulatory Affairs-Nutritionals, for the McNeil Consumer Healthcare Company where he was responsible for the development and implementation of U.S., EU and Pacific Rim legal strategies for the establishment and maintenance of functional food and dietary supplement businesses.
Mr. Young began his career as a Trial Attorney for the Food and Drug Division of the then Department of Health, Education and Welfare in Washington DC, becoming Chief of the Litigation Branch of the Division. Following the government, he joined the Thomas J. Lipton Company as Assistant General Counsel where he was responsible for a wide variety of corporate legal matters including FDA, USDA, and FTC issues. He is a graduate of Middlebury College in Vermont, and the New York University School of Law. He has been active in AFDO for more than 30 years, a member of a number of committees, and currently Chairman of the Board of Trustees of the AFDO Endowment Foundation.
Dr. Jonathan Zack, USDA
Dr. Jonathan (Jon) Zack is a 1997 graduate of the University of Minnesota College of Veterinary Medicine. Jon was a large animal and equine practitioner for five years before joining Veterinary Services in 2002. He has served as a District Veterinary Medical Officer, an Area Veterinarian in Charge and is currently the Director, National Preparedness and Incident Coordination with the U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Surveillance, Preparedness and Response Services. His preparedness activities include Secure Food Supply Plans and the Foreign Animal Disease Preparedness and Response Plan (FAD PReP). His response activities include END, LPAI, MCF, CEM and HPAI.
Dr. Jonathan (Jon) Zack is a 1997 graduate of the University of Minnesota College of Veterinary Medicine. Jon was a large animal and equine practitioner for five years before joining Veterinary Services in 2002. He has served as a District Veterinary Medical Officer, an Area Veterinarian in Charge and is currently the Director, National Preparedness and Incident Coordination with the U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Surveillance, Preparedness and Response Services. His preparedness activities include Secure Food Supply Plans and the Foreign Animal Disease Preparedness and Response Plan (FAD PReP). His response activities include END, LPAI, MCF, CEM and HPAI.
Leo Zadecky, RPh, CDR USPHS, FDA CDER Drug Shortage Staff
After graduating from Duquesne University School of Pharmacy in 1998, Leo worked as a staff pharmacist on the transplant and HIV treatment teams for Stadtlanders Pharmaceutical Company in Pittsburgh, PA. In 2003, Leo Joined the United States Public Health Service, serving in the FDA’s Office of Generic Drugs’ Regulatory Support Branch. In 2009, Leo joined the drug inspectional cadre in the FDA’s New England District Office. His primary areas of investigational focus were in the Drug cGMP and Bioresearch Monitoring programs. After several years in the field, he worked as a Supervisory Investigator with the district’s drug pre-approval program and the district’s pharmacy compounding evaluations. In 2014, Leo returned to FDA’s Center for Drug Evaluation and Research as a Senior Program Officer in the Drug Shortage Staff. CDR Zadecky currently serves as Drug Shortage liaison to the agency’s Office of Regulatory Affairs and CDER Compliance Division.
After graduating from Duquesne University School of Pharmacy in 1998, Leo worked as a staff pharmacist on the transplant and HIV treatment teams for Stadtlanders Pharmaceutical Company in Pittsburgh, PA. In 2003, Leo Joined the United States Public Health Service, serving in the FDA’s Office of Generic Drugs’ Regulatory Support Branch. In 2009, Leo joined the drug inspectional cadre in the FDA’s New England District Office. His primary areas of investigational focus were in the Drug cGMP and Bioresearch Monitoring programs. After several years in the field, he worked as a Supervisory Investigator with the district’s drug pre-approval program and the district’s pharmacy compounding evaluations. In 2014, Leo returned to FDA’s Center for Drug Evaluation and Research as a Senior Program Officer in the Drug Shortage Staff. CDR Zadecky currently serves as Drug Shortage liaison to the agency’s Office of Regulatory Affairs and CDER Compliance Division.