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GCP Auditing Techniques: Using the FDA Compliance Program Guidance Manuals (CPGMs)

While GCP Quality Assurance (QA) in clinical research settings is not an FDA regulatory requirement, the FDA, research sites and industry are trending towards implementing quality assurance programs. The ICH E6(R2) guideline also raises expectations for QA and conveys the expectation that GCP auditing will be performed. Do you know what you need to know about quality assurance auditing? Implementing a GCP QA program closes the loop between quality control (QC) and quality management. Learn how QC and QA compliment each other. Together they allow for greater assurance of GCP compliance and that data being presented within a regulatory submission will be accurate and defensible. We will introduce GCP auditing, review the FDA’s CPGM for Investigators, Sponsors and IRBs, and relevant sections of the ICH E6(2) Guideline.

Speakers:

  • Glenda Guest, CCRA, RQAP-GCP, TIACR, President, Assured of Quality Consulting & Training

  • Lee Truax-Bellows, CCRA, RQAP-GCP, President, CEO, NCRA