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GCP inspections involving FDA investigators to utilize quality improvement

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					Preparing for FDA GCP Inspections – Essentials for Sponsor Companies
This webinar on FDA GCP inspections, by a former FDA investigator, will provide practical information
on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

Description
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.

				
DOCUMENT INFO
Description: FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. Inspection documentation and proper follow-up procedures, Effective techniques and tools that can used to prepare for GCP inspections.