FDA's Clinical Trials Audit procedures companies should conduct as part of its monitoring program

Instructor: Carol Owen
Product ID: 701457
  • Duration: 60 Min

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

Training CD

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Read Frequently Asked Questions

This Clinical Trial Audit webinar / training is designed to provide information on the importance of having an audit plan in place for clinical trials to be submitted to the FDA. Development of an independent audits/data verification and compliance monitoring program will be discussed.

Why should you Attend:
While regulations do not require clinical quality assurance programs for clinical trials, the assurance of quality in well-controlled clinical trials that these programs can offer is a substantial benefit to a sponsoring company. Early detection of quality issues and management of the risks associated with any clinical study can ensure that a clinical trial program will meet the objectives of the sponsor as well as FDA regulations and guidelines. This FDA Clinical Trials Audit training session will include aspects of what an established quality assurance program should include. Additionally, the types of audits and what the audits should cover will also be examined. Details of the FDA inspection program and how to ensure sites are prepared for the inspections will also be reviewed.

Areas Covered in the seminar:

  • Key factors of any quality assurance program.
  • What audits should constitute an audit program for clinical trial sites.
  • Audit plan details.
  • Recommendations regarding site selection for audit, audit activities, audit frequency, trending of audit data, identification of quality issues and risks.
  • FDA Inspection program for clinical trial sites.
  • Most Common FDA findings from clinical site inspections.
  • How to use trended data from audits and common FDA findings to ensure audit program will identify these issues.

Who will benefit:

This webinar will provide valuable assistance to all personnel in:
  • Pharmaceutical
  • Biotechnology
  • CROs
  • Research facilities conducting clinical trials
  • Quality Assurance Personnel

Instructor Profile:
Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training. She has specialized in the pharmaceutical clinical trial business having previously worked for an international pharmaceutical company and two international CROs. She has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials.

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