Ms Betty L. Jones has 33 years of FDA regulatory experience in applying the Federal Food, Drug and Cosmetic Act and related statutes and regulations in three of FDAs six components with multi-district and multi-center experiences. Ms. Jones has experience as a field consumer safety officer, a field and headquarters compliance officer, a regulatory compliance specialist, a Branch Chief and Deputy Office Director.
She has conducted inspections and investigations of food, device, drug and cosmetic establishments, clinical investigators, sponsor monitors, current good manufacturing practices and narcotic treatment programs, prepared regulatory recommendation submissions as a field and headquarters compliance officer.
In her former position as Deputy Director of the Office of Compliance in Center for Drug Evaluation and Research, Ms Jones provided leadership in administering thirty-five nation-wide human drug programs, enforcement policy development, regulatory strategic planning, risk-management strategies and results and program management. She managed and directed a multi-disciplinary staff of one hundred twenty regulatory and scientific personnel engaged in enforcement of compliance programs designed to protect consumers from unsafe or ineffective medical products and promoting and protecting public health.
Ms. Jones provided executive leadership, oversight and direction in strategic planning and problem solving, program and results management, and enforcement policy and strategy development. She provided vision and direction in identification of political, regulatory, economic, technological and administrative issues affecting program operations and regulatory decision-making through an intimate understanding of regulatory requirements, processes and systems, a network of appropriate contacts and an in-depth knowledge on internal agency operations.
In her previous position as the Chief of the Regulatory Management in the Office of Compliance, she was responsible for the development, direction, implementation and regulatory evaluation and support of the Centers Bioresearch monitoring, adverse drug experience and narcotic treatment programs. She consistently analyzed and evaluated establishment inspection reports and supporting documents to assure the appropriateness of the statute sections that were in violation, determine the conclusiveness of the evidence, and explore appropriate alternative courses of action available for securing compliance.
Ms Jones designed, directed and monitored strategies for criminal investigations and federal court cases involving violations of the new drug, bioresearch monitoring and the adverse drug event reporting provisions of the Act and appropriate provisions of the Code of Federal Regulations, Title 21 and Title 18.
Ms. Jones began her FDA career as a consumer safety officer in the Orlando District Office conducting inspections and investigations covering the full range of products under FDAs jurisdiction. She holds a B.S. degree in biology graduating magna cum laude and is currently completing a Masters in Public Health. She is the recipient of numerous Department, Agency and Center awards and is an alumna of FDAs Leadership Development Program, the Federal Executive Institute, OPM Executive Leadership Development Program and a Harvard University Senior Executive Fellow.
Ms Sandra N. Whetstone has over 35 years of FDA regulatory experience in applying the Federal Food, Drug and Cosmetic Act and related laws to resolve a variety of industry non-compliance issues covering the full range of products under FDAs jurisdiction.
In her most recent position as Director of the Division of Compliance Management and Operations, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration, she provided strategic and policy leadership to division staff with oversight over all of the Agencys regulatory actions including; pharmaceuticals (humans and veterinary), biologics, medical devices, food and cosmetics, the Food, Drug and Cosmetic Act, and related regulations.
Ms Whetstone provided leadership in the development of enforcement strategies for a number of complex pharmaceutical, biologics, and medical device cases that resulted in the efficient removal of, and prevention of adulterated products from entering the market place. She was one of the founders of Team Biologics, the new inspection and compliance program for biologic therapeutic products and managed the ORA compliance function of Team Biologics.
Ms Whetstone was in the approval chain for all of the Agencys compliance programs and policy documents. She managed the Agencys Recall Operations and led a major reengineering of the Agencys Recall procedures. She has conducted numerous seminars for the industry as well as the states and other governments. She developed and conducted internal professional training for agency personnel to ensure consistent application of the laws and relevant scientific and technical standards.
Ms Whetstone's field experience includes Acting Director Boston District Office, Acting Director New York District Import Operations Branch, Acting Director Baltimore District Compliance Branch, Acting Director San Juan District Compliance Branch, Acting Director Minneapolis District Compliance Branch and Investigator Baltimore District Office.
In her previous position as Director of the Program and Enforcement Branch, Division of Programs and Enforcement Policy, Office of Seafood in FDAs Center for Food safety and Applied Nutrition, she managed a professional staff with diverse backgrounds in scientific and technical fields engaged in administering the Food, Drug and Cosmetic Act with respect to seafood. She was one of the founders of the FDA's Office of Seafood and created the Program and Enforcement Branch.
Ms Whetstone directed the cooperative Shellfish Program and served as the Agencys liaison with the Interstate Shellfish Sanitation Conference (ISSC) with whom she negotiated the first control matrix for Vibrio vulnificus in Gulf Coast Oysters. She improved the quality of imported seafood through strategic enforcement and outreach activities with foreign governments, producers, and manufacturers.
Ms Whetstone's international experience regarding food import issues is extensive. She has conducted numerous visits to major food producing nations and trained commercial producers and government agencies on U.S. market requirements and regulatory standards. She directed and coordinated the development of numerous compliance programs for all segments of the seafood industry. She also represented the agency in many national and international forums.
Prior to Ms. Whetstones management positions, she served as a Compliance Officer in the Case and Advisory Branch, Division of Regulatory Guidance, Office of Compliance in FDAs Center for Food Safety and Applied Nutrition. She interpreted and applied the Food Drug and Cosmetic Act, the Public Health Service Act, the Fair Packaging and Labeling Act, and other related Acts and FDA policies in resolving regulatory problems.
In this capacity, she also reviewed and evaluated Establishment Inspection Reports (EIRs), analytical data and made decisions on the full range of regulatory case recommendations from the field office.
Ms WHetstone also served a stint as Recall Coordinator, and worked in each of the specialty areas: Nutrition and labeling/Food Standards, Low Acid Canned Foods (LACF), Filth/Sanitation, Fishery and Seafood Products, and Food Additives and Good Laboratory Practices (GLPs).
Ms. Whetstone started her FDA career as an analytical cosmetic chemist in the Bureau of Foods (predecessor to the Center for Food Safety and Applied Nutrition). She holds a B.S. degree in chemistry and a minor in mathematics. She is the recipient of numerous Department, Agency and Center awards and is an alumna of OPM Executive Leadership Development Program, George Washington University and Harvard University.
