SQA Webinar: Introducing Global Guideline for GCP Audit

This online webinar will be given via Zoom.

Presented by: Bernadette Bowen, MapLight Therapeutics; Leslie Paul, Melah GxP;  Klaus Goodwin, Emergent BioSolutions 

Webinar Category: Compliance

Regulatory Area of Interest: GCP

Description:

The Global Guideline for Good Clinical Practice (GCP) Audit was originally developed by RQA, SQA, and JSQA and was issued in 2014. At that time, according to definition, auditing was a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, written procedures, GCP, and the applicable regulatory requirement(s).

Recently, the guideline was revised by RQA / SQA / JSQA GCP Committees to reflect changes in ICH E6 (R3) Guideline for Good Clinical Practice, information technologies, regulations, and industry best practices. Specifically, ICH E6 (R3) describes the need to perform audits using a risk-based and risk-proportionate approach, focusing on the use of risk identification to prioritize areas of high risk, e.g. informed consent, trial endpoints, and service provider oversight. Audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial.

This webinar will introduce the guideline and to go over key points including risk-based and risk-proportionate approaches regarding areas of auditing considered as high-risk, i.e., Service Provider, Investigator Site, TMF and Process & Systems audits.  Following the presentation, a Q&A will be conducted where the audience will have an opportunity to ask questions regarding the use of the guideline.

RQAP Re-registration units approved: TBD