Course offering number:0812-302
Course ID:
2203
System Validation, GAMP Harmonization and P.A.T
15-17 December 2008
Amsterdam, The Netherlands
Dr. Sandy Weinberg; Associate Professor, Health Care Management, Clayton State University
Dr. Sandy Weinberg is a professor of Health Care
Management at the School for Professional Studies of
Clayton State University, part of the Georgia State
University System. He is teaching and researching
Regulation and Biodefense. 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. He has
consulted to the FDA, other regulatory agencies
worldwide, and the industry. 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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