Course offering number:0901-303
Course ID:
2232
FDA Quarterly Briefing–January 2009
January 13, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
90 Minute Accredited Online Training
Dr. Sandy Weinberg Independent Consultant to FDA Regulated Industries, has consulted for the FDA, Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health
Dr. Sandy Weinberg, is currently a professor of Health Care Management in the School for Professional Studies at Clayton State University, part of the Georgia State University System. He is teaching and researching Regulation and Biodefense. Dr. Weinberg 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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