CITI Program Webinar Demo - FDA Inspections of GMP Facilities

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.

Learning Objectives:
- Describe the process of U.S. Food and Drug Administration (FDA) inspections of Good Manufacturing Practices (GMP) facilities.
- Discuss how a site can be “inspection ready” at all times.
- Discuss possible FDA inspection outcomes.

Presented by: Susan Leister, MBA, PhD, CQA, CSSBB – Technical Resources International, Inc.