FDA Approval Expert Witnesses in Georgia

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.

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.

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.

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.