Course offering number:1007-708
Course ID:
2405
CDRH: Get Ready for Changes!
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Dr. Sandy Weinberg, Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; retired regulatory professional from the drug, device and vaccine industries
Dr. Weinberg is teaching and researching Regulation and Biodefense. He is a consultant to the FDA regulated industries and is a former
consultant to the FDA and other international regulatory agencies including Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health.
He has been a leader in the field of system validation for more than twenty years, and a practitioner in regulatory submissions, auditing,
international liaison and biodefense vaccine development. Dr. Weinberg is the author of numerous books and articles, including The GALP
Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory
Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands.
Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an
investor in and Board member of several international biomedical companies.
Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and
certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an
Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg’s practice is centered in
the US, Western Europe and Israel.
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