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Description
Learn the overall approach taken by the FDA during a GMP facility inspection and understand how to best prepare for an inspection at your facility and how to become inspection ready at all times. The webinar reviews key do’s and don’ts along with vital inspection best practices, including performing internal audits and conducting mock inspections. It concludes by examining case studies and trends in FDA 483 findings and FDA warning letters to understand possible outcomes of GMP inspections.
Audience
Compliance Professionals, General Counsel, Pharmaceutical Manufacturers, Research Administrators, Research Staff
Meet the Presenter
Susan Leister, MBA, PhD, CQA, CSSBB – Technical Resources International, Inc.
Dr. Susan Leister is VP of Quality and Compliance at Technical Resources International Inc., with over 20 years experience in the pharmaceutical, biotech, and medical device industries. She has a Bachelor’s Degree in Biochemistry and Molecular Biology, an MBA, a Doctorate in Organization & Management with a focus in Leadership.
