ComplianceOnline

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

Instructor: Kimberly Kiner
Product ID: 701721
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$450.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits.

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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