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clinical research training

BEING INSPECTION READY: UNDERSTANDING THE FDA BIMO INSPECTION PROCESS FOR SITES AND SPONSORS

COURSE DESCRIPTION:

The goal of this training is to provide insight on the importance of Good Clinical Practice (GCP) to help ensure sites and sponsors are prepared for the FDA. Learners will understand what the FDA is looking for during inspections, what to expect, and provide case studies and exercises to prepare for the FDA’s arrival. Attendees will also gain an appreciation for how to be inspection ready throughout a study.

LEARNING OBJECTIVES:

  • Anticipate FDA GCP expectations for drug and medical device studies by reviewing the FDA BIMO Guidances
  • Recognize sponsor/CRO/investigator responsibilities applicable to compliant studies
  • Describe best practices for creating and maintaining high quality documentation in research at sites and in sponsor files
  • Understand the mechanics of FDA inspections and describe at least three (3) recommendations to help sites and sponsors be inspection ready
  • Recognize how to think like an FDA inspector

COURSE OUTLINE

AGENDA: 9:00am – 3:00pm 

  • Mechanics of an FDA inspection
  • Common FDA Warning Letter Findings
  • Review of the FDA BIMO Inspection Guidances for Sponsors/CROs and Investigative Sites
  • Preparing For and Hosting Successful Inspections
  • Responding to an FDA Form 483

TYPE

In Person Training – At IMARC or Your Location

CONTINUING EDUCATION CONTACT HOURS (CEUs)

5.0 hours (0.5 CEUs)

KNOWLEDGE LEVELS:

  • Intermediate
  • Experienced

WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion

Training Solutions For These Roles

  • Sponsors/CROs working with investigative sites for overall study inspection readiness
  • Project Managers and Clinical Research Associates 

  • Auditors/Monitors
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