Course offering number:0809-201
Course ID:
1887
Analytical Methods Validation for FDA Compliance
September 8-10, 2008
Burlingame, CA
J. Mark Green, Ph.D.; Principal Investigator, Bristol-Myers Squibb Medical Imaging
J. Mark Green Ph.D. is Director of Pharmacy and Analytical
Development at Bristol-Myers Squibb Medical Imaging. Dr. Green
is responsible for the development, validation, and transfer of
analytical methods for drug substances and drug products. He is
also responsible for stability testing, analytical support of safety
assessment studies, and the preparation of method-related
sections of regulatory submissions. Dr. Green has over 20 years of
experience in drug development, and previously worked for the
DuPont and DuPont Merck Pharmaceutical Companies. He has
published and lectured on analytical method validation, and on
applications of HPLC, TLC, and Chiral Chromatography. Dr. Green
received his Ph.D. in Analytical Chemistry from the University of
Illinois.
David E. Wiggins; Associate Director of Analytical/Stability R&D, Schering-Plough Consumer Health Care Products
David E. Wiggins is Associate Director of Analytical/Stability R&D
for Schering-Plough Consumer Health Care Products. Since joining
the company in 1982, Mr. Wiggins has worked in both Quality
Control and Research and Development with responsibility for
Method Optimization, Method Validation, Method Transfer and
Stability (both pre- and post-market). These responsibilities have
additionally included involvement with every NDA submission and
every FDA inspection of the division since 1991.
Mr. Wiggins has over 25 years experience in the pharmaceutical
industry in both a QC and an R&D setting. During this time, he has
been instrumental in establishing and updating method validation
policy to be consistent with the changing regulatory requirements.
Mr. Wiggins has frequently lectured on analytical method validation
principles in the US, Puerto Rico, and throughout Europe. He has
been active in submitting comments and validated methods to the
U.S. Pharmacopeia and has been an invited speaker to FDA,
university, and industry conferences.
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