Pharmaceutical and FDA Regulations Expert Witness
Pharmaceutical and FDA Regulations | E-007167
Expert Qualifications
This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.
Bio Snapshot
Location: Savannah, Georgia
B.A., LaSalle College
M.S., St. Joseph's College
M.B.A., Temple University
Published, 10+ articles, 5 books (management books and detective novels)
Patents, Holds two patents and has a patent pending on inventions.
Adjunct Instructor. Science, Business and Food and Drug Administration Regulations at various Philadelphia area colleges.
Current, Expert Witness/Subject Matter Expert for attorneys in Pharmaceutical cases.
Current, Founder/Principal, consulting services for pharmaceutical firms.
Former, Director, Science Branch, Philadelphia District FDA
Former, Assistant Director of Laboratories, The West Company
Former, Senior Chemist, various pharmaceutical companies.
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