Auditing Clinical Trials for GCP Compliance

Duration: 90 Minutes
Audits from either regulatory bodies and/or the sponsor companies are usual during the development of a clinical trial. The results of an audit affect both, the site and the sponsor of the clinical study. Good preparation for an audit starts from the beginning of the trial by identifying the risks of noncompliance.
Auditing Clinical Trials
Instructor: Calin Popa
Product ID: 500731

Why Should you Attend:
With the growth of the Pharmaceutical and Biotechnology industry, audits are getting more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other hand, the sponsors also multiplied the audits from their part to downsize the risk of noncompliance during the trial.

This presentation will help you to understand, correct and prevent audit findings.

Objectives of the Presentation:
The objectives of the presentation are to talk about:
  • ICH guidelines and Good Clinical Practice (GCP)
  • Differences between protocol deviations/violations/exceptions
  • Understanding compliance
  • Most frequent audit findings
  • Audit preparation
  • Responding to audit findings
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Clinical trial sponsors study team
  • CROs study team
  • Study Managers, Clinical Team Leads, CRAs
  • Principal Investigators, Site Managers and Study Coordinators
  • Regulatory Compliance Associates and Managers
$300
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Calin Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries.

He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.


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