This short course will provide information on how to build quality into a clinical trials program. A record number of FDA inspections, both domestic and international, and OHRP audits have resulted in an increased number of warning letters to sponsors, principal investigators, and IRBs. Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with good clinical practice expectations. Participants will also learn about the considerations for non-compliance and the types of findings in an audit that can lead to regulatory problems. This course will describe the role of the FDA and the preparation of a site for an FDA inspection. We will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do in case your site is chosen for an FDA inspection. There will be a discussion on how to host the audit and how best to prepare for the actual audit. The audience will be taught some of the do's and don'ts of a successful inspection.
This short course is designed for quality assurance (QA) and clinical staff in companies, as well as professionals working in pharmaceutical/biological companies that are involved in clinical trials and QA activities for clinical research.
At the conclusion of this course, participants should be able to:
Describe how to prepare for an FDA inspection
Describe how to respond to an FDA inspection
Examine audit findings including their impact on quality research