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Philosophy
CCS’s 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 FDA’s 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 FDA’s 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 FDA’s 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 Agency’s 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 Agency’s 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 FDA’s 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 Agency’s 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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