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FDA Approval Experts in Georgia
See more FDA Approval Expert WitnessesThis 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.
Founder/Principal, A consulting services for pharmaceutical firms
Master of Business Administration (MBA), Temple University
Savannah,
Georgia
This expert has more than a decade of experience in pharmacy practice and pharmaceutical marketing. He earned his PhD in pharmacy care administration from the University of Georgia following a BS in pharmacy from Ohio Northern University. The expert is certified in pharmacy-based immunization delivery and is a member of numerous professional societies. He previously served as pharmacist for Rite Aid and as an assistant professor of pharmacy administration at the Georgia Campus School of Pharmacy. The expert currently serves as an associate professor of pharmacy administration at a GA medical school.
Administrator, A Major Medical School in GA
Doctor of Philosophy (PhD), University of Georgia
Winder,
Georgia
This highly-qualified pharmacist earned her PharmD at the University of Georgia and is a licensed pharmacist in the state of Georgia. Her work focuses on ambulatory care pharmacy, as well as transitions of care, patient education, cardiology, diabetes, and COPD. She is active in her field as a member of the American College of Clinical Pharmacy and the American Society of Health System Pharmacists. She has formerly served as a pharmacist at Atlanta Veterans Affairs Medical Center, Athens Veterans Affairs Community Outpatient Clinic and Mercy Health Center. This expert currently serves as a clinical associate professor at a college of pharmacy and as an ambulatory care clinical pharmacist at a major medical center in Georgia.
Clinical Associate Professor, A University in GA
Doctor of Pharmacy (PharmD), University of Georgia
Tucker,
Georgia
This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.
Legal Consultant and President, International Standards and Regulations Consulting Firm
Doctor of Philosophy (PhD), University of Kansas
Marietta,
Georgia
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FAQs for Fda Approval Expert Witnesses
What is the role of an FDA Approval expert witness in a legal case?
An FDA Approval expert witness provides insight on regulatory compliance, drug approval processes, and medical device clearance. They can testify on whether proper procedures were followed.
What types of cases might require an FDA Approval expert witness?
Cases involving pharmaceuticals, medical devices, food safety, and cosmetics often require an FDA Approval expert witness. These experts are crucial in product liability or patent infringement cases.
How can an FDA Approval expert witness assist in a pharmaceutical litigation case?
In pharmaceutical litigation, an FDA Approval expert can provide testimony on drug development, clinical trials, labeling requirements, and post-market surveillance to establish if there was any negligence.
Are there subspecialties within the field of FDA Approval for expert witnesses?
Yes, some experts specialize in specific areas like pharmaceuticals, medical devices, biologics, dietary supplements, or food products depending on their experience with FDA regulations.
Why is it important to hire an FDA Approval expert witness with recent industry experience?
Regulations and guidelines from the FDA frequently change. An expert with recent industry experience will have up-to-date knowledge about these changes and how they impact your case.
How does Expert Institute select its FDA Approval expert witnesses?
Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.