FDA Inspections of GMP Facilities: How to Be Inspection Ready

Discusses the FDA’s approach to inspecting GMP facilities and the ways that facilities can prepare for inspections.

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About this Webinar

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.

Webinar Demo:

Release Date: April 21, 2022

Language Availability: English

Suggested Audiences: Compliance Professionals, General Counsel, Pharmaceutical Manufacturers, Research Administrators, Research Staff

Organizational Subscription Price: Included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content

FDA Inspections of GMP Facilities: How to Be Inspection Ready

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

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.

Recommended Use: Required
ID (Language): 20580 (English)

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