Preparing for FDA GCP Inspections - Essentials for Sponsor Companies

Instructor: Kimberly Kiner
Product ID: 701923
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2012

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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.

Course "Preparing for FDA GCP Inspections - Essentials for Sponsor Companies" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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