Fundamentals of FDA's Clinical Trial Audits - A Must-Know for Audit preparation

Instructor: Kimberly Kiner
Product ID: 701721
  • Duration: 60 Min
This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits.

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2010

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Why Should You Attend:
Often times GCP audits, particularly from FDA investigators, can be seen as an intimidating and adversarial experience as opposed to a process used to improve quality and ensure compliance. Overall, audits are an important part of the GCP process that helps prove that the final study product is safe and effective for consumer use.

This webinar will provide an overview of auditing and cover techniques used by auditors that will help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits. Learn the most common audit deficiencies, audit planning techniques in accordance with GCP regulations and FDA guidelines used for audits.

Areas Covered in the Seminar:

  • Differentiation of work of an auditor vs. Clinical Research Associate.
  • Most common audit deficiencies noted among sites and sponsors.
  • Techniques used in audit planning.
  • Factors involved in selection process.
  • Overview of GCP regulations and FDA guidelines used for audits.
  • Audit documentation and proper follow-up procedures.
  • Overview of Preparing for Audit.

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,BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at USFDA as a GMP FDA investigator and transitioned into the GCP industry working for Quintiles (CRO) and sponsor companies such as Johnson & Johnson, Berlex Laboratories (now Bayer), Galderma and others. She has held many positions over the years such as in-house CRA, Regional CRA, Sr. CRA and Independent CRA Consultant and has been involved in projects as a GCP Auditor and Trainer.

She has diverse experience in therapeutic areas of Cardiovascular, CNS, Medical devices, InVitro diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health. Mrs. Kiner is certified and an active member of ACRP (Association of Clinical Research Professionals).

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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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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