From RxTi's Webinar Series: Good Clinical Practices (GCP)

This webinar will help research sites prepare for an FDA audit. Key issues that will be covered include understanding what may trigger an FDA audit, understanding what the FDA will be looking for during an audit, and common findings of FDA audits. Being proactive in your preparation can make the difference between a positive outcome that requires little or no follow-up, and the burden of developing and implementing a comprehensive action plan.

What You’ll Learn

• What FDA Looks for During an Audit
• Metrics and Common Findings
• How to Proactively Prepare for an FDA Audit
   

About the Speakers:

Madeleine Williams, MA, CIP, is a Director in Huron’s Life Sciences practice. Maddie has over 10 years of research experience and her specific areas of experience include the management of engagements focused on research project management, Institutional Review Board (IRB) operations structure and function, and IRB interim staffing. Maddie’s focus is on helping organizations to improve their processes, enhance research compliance and improve efficiency.

Lynn Smith, JD, CIP, is a Manager in Huron’s Life Sciences practice. Lynn has seventeen years of experience in research administration and regulatory compliance. Her experience includes Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) administration, research compliance assessment, and Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation.