Course offering number:0803-703
Course ID:
2205
Getting a Share of the BioDefense Grant Billions
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Dr. Sandy Weinberg; Vice President, Regulatory and Quality Assurance, Tikvah Therapeutics, Inc.
Dr. Sandy Weinberg VP, Regulatory, TIKVAH Therapeutics, is former Sr. Director, Fast Trak Vaccines, GE Healthcare and has been the leader in the field of system validation for more than twenty years. He has consulted to the FDA, most other regulatory agencies worldwide, and the industry on techniques for assuring data quality and control since first identifying significant data problems in 1976. Dr. Weinberg is the author of numerous system validation books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, and System Validation Annual.His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Dr. Weinberg served as a professor of biomedical informatics at Muhlenberg College in Allentown, Pennsylvania, USA. He is also a member of the board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands, and 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 related to system validation. Recent projects include the auditing and certification of a chromotography control system; auditing and advisory services related to a pharmaceutical inventory system; and validation of a Laboratory Information Management System (LIMS). Much of Dr. Weinberg’s practice is centered in Western Europe and Israel.
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