Auditing Laboratories Conducting Assays Supporting Biologics
July 2, 2021 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit. The first steps in preparing for the audit involves determining necessary personnel required for the site visit (quality assurance and subject matter experts), understanding the purpose of the audit, and triaging the documents necessary for review. The initial steps are best handled by advance planning, even for routine audits. Routine audits can have templates created to assist with performance of the audit, but care should be taken to identify and incorporate examination of any new processes performed by the laboratory. Templates may cover basic audit procedures and requests, such as in prequalification of vendors. Audits for cause focus on specific issues and require additional planning to uncover the root cause of the quality issue. This webinar will address key points to assess during the preparation and performance of GMP/GLP laboratory audits for laboratories conducting assays supporting biologics.