This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
Why Should You Attend:
During this training session, attendees will expand their understanding of FDA inspections, the general purpose of the inspection, preparation strategies, and outcomes to assist clinical sites in preparing for an inspection with a culture of compliance. The course will discuss the BIMO inspection program, looking at FDA statistics and what one should expect during a clinical site inspection. Also, it will clarify key terms and responsibilities while refreshing clinical sites’ knowledge of the possible outcomes of an FDA inspection and how to respond to the FDA. This session will also review some helpful tips for inspection readiness.Learning Objectives:
- Discuss key terms and responsibilities related to FDA inspections
- Discuss the purpose of the BIMO inspection program
- Review the general purpose and overall process of an FDA inspection
- Enhance your inspection preparation strategies
- Understand how to respond to the FDA
Areas Covered in the Webinar:
- Discuss key terms and responsibilities associated with an FDA inspection
- Discuss the BIMO inspection program
- Review the general purpose of an FDA inspection
- Review preparation strategies
- Discuss how to respond to the FDA following an inspection
Who Will Benefit:
- Quality Assurance/Quality Control Managers
- Directors
- Auditors
- Regulatory/Compliance Staff
- Study Coordinators
- Clinical Research Associates
Course Provider
Susan Muhr Leister,
