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John E. Snyder, Senior Consultant
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John
Snyder is a quality professional with 25 years experience in industry with companies
including Merck, Novartis and Johnson & Johnson. His senior management and
consulting experience encompasses the biologic, biopharmaceutical, drug, medical
device and medical gas industries. John has thousands of hours of hands-on experience
working with FDA investigators and thought leaders across many districts. He
has helped companies to navigate through FDA enforcement actions, including
warning letters and consent decrees with effective corrective and preventive
action planning and implementation. He has also prepared firms for routine FDA
inspections, as well as pre-approval inspections for new products.
John's expertise includes quality system assessment, development and planning.
He is an expert in helping clients to design quality systems that are both regulatory
secure and effective business processes. His approach integrates the quality
function and the quality system into the strategic planning process of the business
to help sustain regulatory compliance.
John has lectured and conducted workshops in the area of crisis management
based upon his experience with handling suspected product tampering of over
the counter medications. He is an invited speaker for key professional organizations
and has published on various quality and regulatory topics.
John has a B.A. in Biology and is a registered medical technologist. He holds
an M.S. in Animal Pathology from the University of Rhode Island and an M.S.
in Pharmaceutics from Temple University School of Pharmacy. He did special studies
at Yale University in Diagnostic Virology. John is a member of the American
Society for Quality, the Regulatory Affairs Professional Society, the Parenteral
Drug Association and the American Management Association. He is also a member
of the scientific honor society, Sigma Xi.
John is very effective in helping organizations to design effective quality
systems and sustainable regulatory compliance in both crisis and preventive
circumstances.
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