Auditing vs. monitoring, defining the purpose, application and process

Instructor: Arash Amirpour
Product ID: 701707
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

In this Clinical Trial audit training learn risk-based approach to the process of monitoring and auditing clinical trial.

Why Should You Attend:
When conducting a clinical trial, the regulatory bodies expect from the sponsor to be in control of the quality of the trial. More specifically the sponsor should monitor (QC) and audit (QA) the trial in order to address this expectation. In addition, monitoring and auditing the trial provides the sponsor with information and insight that perfectly serves the purpose of protecting, as well as improving, the sponsor’s business interests by helping sponsor preventing legal, ethical or financial issues, related to possible error or trial misconduct, proactively from happening.

While monitoring, as a Quality Control activity, is the line’s responsibility, auditing should be performed by an independent Quality Assurance function that reports to the sponsor’s management.
Designing the monitoring and auditing program of a trial is depending on numerous factors such as :The Indication, Trial Phase, No of countries, recruiting sites, screened/enrolled subjects, Sponsor’s experience, Recruitment rate, Trial complexity, Amount of data generated pr. enrolled subject, Number and type of vendors involved etc. In addition, each trial setup introduces specific factors that should be identified and taken into account, during the planning phase.

With a risk-based approach this webinar will guide the attendees through an overview of all the processes of monitoring and auditing from the planning phase to the conduct, documentation, and finally, the application of the information obtained from these activities.

Areas Covered in the Seminar:
  • Background and Definitions.
  • Roles and Responsibilities.
  • Symbiosis of Monitoring & Auditing.
  • Planning & Conduct of Monitoring & Auditing.
  • Identifying & Handling Possible Fraud And Misconduct.
  • Ensuring A successful Trial Conduct.
  • Continuous Improvement.
  • Past Lessons vs. Future Trials.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Ros and Research Facilities Conducting Clinical Trials including:
  • Corporate Management
  • Managers in Clinical Development and Project Leaders
  • Quality Assurance Managers and Auditors
  • Monitors (CRAs)
  • Clinical Operations Staff
  • Regulatory Compliance Staff

Instructor Profile:
Arash Amirpour, Graduated in 1999 with Master Degree in Natural Sciences from the Technical University of Denmark.Ever since graduation, his professional work has been dedicated to the pharmaceutical industry. He has obtained experience in the manufacturing area and GMP regulation, while working as an Analytical Chemist in Novo Nordisk and as an QA-Engineer in a subsidiary of Ferring Pharmaceuticals.

In January 2003, he shifted to the area of clinical development and pharmacovigilance by joining International Clinical Quality Assurance department in Nycomed. He left Nycomed as a Senior Auditor to start his position as the Director in CliniQAl Consult Corp, at the end of 2007.

Mr. Amirpour is a certified ISO-9001:2000 Lead Auditor and a very active member of the Pharmaceutical industry. He is multilingual and has experience from several cultural backgrounds. He takes the human relations as an important and at times overseen factor of the absolute success in any pharmaceutical collaboration.

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