What are the GCP Violations Commonly Found During an FDA Investigator Site Inspection/Audit, and How to Avoid Them

Event Information
Product Format
Prerecorded Event
Charles H Pierce, MD, PhD, FCP, CPI
90 minutes
Product Description

How to Ensure Your Site is Prepared for an FDA Site Inspection and Audit. 

With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of Protocol and Good Clinical Practices (GCP) violations has gained more importance, evident by the increase in Warning Letters. To know the protocol and other GCP violations that an FDA audit and inspection may reveal is a great insight for your site. In this case, the adage “forewarned is forearmed” clearly applies.

GCP investigator site audits are a routine and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as a Principal Investigator, a study coordinator, a monitor, or even as the IRB, chances are that you may be audited.

Join expert speaker Charles H. Pierce, MD, PhD, FCP, CPI in this webinar to uncover the most frequently found GCP violations / mistakes that are often found during the audit process. In addition, you will learn how to prevent audit findings you wish were not there. This webinar will review FDA inspection program details and how to ensure your site is prepared for an inspection. Focus areas would be key component identification of a good audit program.

Charles will give you helpful hints to help you avoid the common GCP mistakes and hints to enhance the overall audit experience. Attending this webinar is a good step toward the challenge of learning the FDA audit processes and why a knowledgeable PI is so important.

Session Highlights:

  • What does the FDA look at when Auditing/Inspecting a study
  • The regulatory requirements for the BIMO program
  • The studies targeted for auditing and what is look for
  • The nature of adequate oversight of all staff and non-staff
  • The importance of Protocol knowledge in preventing errors
  • How do sites prepare for an audit / inspection
  • What happens after an inspection / audit is done?

Learning Objectives:

  • Defining and avoiding the 4 mistakes found during an audit
  • Learning the 3 strategies to improve audit outcome
  • Discuss on audit preparation tools
  • Learn how to prevent each of the top Audit findings that would lead to a 483
  • Compare your experience in an Inspection with the examples given

You will learn from a collection of rare books and resources on FDA investigations and audits, including:

  • FDA Inspections for Clinical Investigators; Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: DHHS, FDA, January 2006
  • Compliance Program Guidance Manual-CPGM 7348.810. Advises FDA on procedures to follow for sponsors, IRBs...
  • Compliance Program Guidance Manual-CPGM 7348.811. Advises FDA on procedures to follow for Investigators
  • Wool, Liz, Good Training Practice 101: A Primer for Employee Training Plans, ACRP MONITOR, June 2008
  • Pierce, CH,Common GCP Violations and Site Mistakes: How to Avoid Them; 26(5), MONITOR, September 2012
  • Pierce, CH, The New Status of Physician Investigator Certification, The MONITOR, 26(7), 70-71, December 2012
  • The Adverse Event / Causality algorithm

Who should attend:

Personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to Conduct Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA / QC auditors and staff, & Clinical Research Data managers


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About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI

From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
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