Company History

Comprehensive Compliance Solutions (CCS), LLC was founded in 2005 by Betty L. Jones, former Deputy Director of the Office of Compliance in the FDAs Center for Drug Evaluation and Research and Sandra N. Whetstone, former Director of the Division of Compliance Management and Operation, Office of Enforcement in the Office of Regulatory Affairs of the U. S. Food and Drug Administration.

CCS offers regulatory expertise with all products and industries regulated by the FDA. CCS is comprised of a network of former senior ex-FDA executives with extensive experience resulting from policymaking and decision-making positions in the agency. We are a highly respected firm based in the Washington metropolitan area with decades of combined FDA and industry experience. We understand FDAs expectations and our insight can help you navigate through FDA policies and procedures.

Philosophy

CCSs consulting philosophy is to provide specialized solutions that combine science, technology and business to achieve well-crafted compliance strategies that are risk-based and to build in quality from the start by rigorous application of professional, industry and cGMP standards.

Betty L. Jones, PhD, MPH

Dr.  Betty L. Jones has 34 years of FDA regulatory experience in interpreting and 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 experience. She has experience as a field consumer safety officer, a field and headquarters compliance officer, a regulatory compliance specialist, a project manager, a Branch Chief, Deputy Office Director and Acting Office Director.

As Acting Director/Deputy Director of the Office of Compliance in Center for Drug Evaluation and Research, Dr. 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 sixty 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.

Dr. 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 of internal agency operations.

Dr. 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. in biology and a M.S. and Doctorate in public health graduating magna cum laude. She is the recipient of numerous Department, Agency, Center and outside awards and is an alumna of FDAs Leadership Development Program, the Federal Executive Institute, the OPM Executive Leadership Development Program and Harvard University.

Sandra N. Whetstone

Ms. Sandra N. Whetstone is a former FDA executive with more than 35 years of experience and is a recognized expert in U.S. Food and Drug Law, the Public Health Service Act and related statues. Her primary area of expertise is in the practical application of the U.S. Food, Drug and Cosmetic Act, promulgating regulations under the Acts, developing and implementing compliance programs for the FDA regulated industries, and developing enforcement strategies for effective compliance and consumer protection covering the full range of products under FDA's jurisdiction.

As Director of the Division of Compliance Management and Operations, Office of Enforcement, Office of Regulatory Affairs, she provided strategic and policy leadership to a division staff with oversight over all of the Agencys regulatory and administrative actions involving: pharmaceuticals (human and veterinary), biologics, medical devices, food, including dietary supplements, cosmetics and product recalls. Ms. Whetstone was in the approval chain for all of the Agencys compliance programs and policy documents. She has developed and conducted numerous seminars for the industry, states and other governments.

Ms. Whetstone's field experience includes details as 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.

Ms. Whetstone spent the first part of her career in FDAs Bureau of Foods (predecessor to the Center for Food safety and Applied Nutrition (CFSAN) where she served as an analytical chemist prior to moving into the area of Regulatory Affairs as a compliance officer. Her food experience includes serving as Director of the Program and Enforcement Branch in the Office of Seafood in CFSAN, where she had oversight of the Agencys seafood program including the Cooperative Shellfish Program.  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 food industry. She also represented the agency in many national and international forums.

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.

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