GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.

In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

This audio conference covers:

• The most common FDA inspection deficiencies noted among sites and sponsors
• Overview of GCP regulations and FDA guidelines used for inspections
• Strategies used in FDA’s inspection planning
• The areas that are reviewed during GCP inspections
• Inspection documentation and proper follow-up procedures
• Effective techniques and tools you can use to prepare for GCP inspections

About the speaker:

Kimberly Kiner, BSc, CCRA is president of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring, co-monitoring and GCP compliance services to sponsor companies, CROs and clinical investigators. Kimberly has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at FDA and transitioned into the GCP industry working for CRO and sponsor companies. She has held many positions over the years in CRA, auditing or and managerial roles. She has diverse experience in therapeutic areas of Cardiovascular, CNS, Medical devices, InVitro diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health.

Who should attend?

• Clinical Research Associates
• Compliance/GCP Quality Assurance
• Site Staff/ Study Coordinators
• Study Managers
• Clinical Investigators