This webinar on FDA GCP inspections will provide practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Why Should You Attend:
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 webinar, 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.
Areas Covered in the Seminar:
- The most common FDA inspection deficiencies noted among sites and sponsors.
- Overview of GCP regulations and FDA guidelines used for inspections.
- The areas that are reviewed during GCP inspections.
- Inspection documentation and proper follow-up procedures.
- Effective techniques and tools that can used to prepare for GCP inspections.
Who Will Benefit:
This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:
- Clinical Research Associates
- Compliance/GCP Quality Assurance staff
- Study Managers
- Site Staff/ Study Coordinators
- Clinical Investigators
Instructor Profile:
Kimberly Kiner, has 15 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 as a CRA, auditor and other managerial roles and has been involved in many GCP inspections over the years.
