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Auditing Clinical Trials for GCP Compliance
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Key Benefits of Attending
This in-depth workshop teaches practical, immediately usable techniques which top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. These techniques are useful when auditing clinical trials which employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). The workshop will enable you to:
- Apply techniques used by monitors and auditors, to better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within your own organizations.
- Develop and utilize Quality Systems (QS) at clinical sites to improve your performance.
- Engage Simple, Efficient & Effective QS processes for use by clinical site personnel
Who Should Attend
This course has been specifically designed for:
- Clinical Quality Assurance Professionals who audit the quality of clinical trials
- Clinical Research Associates (CRAs) and Managers, Project Leaders, and Medical Monitors who want to enhance their effectiveness
- Regulatory Affairs Professionals responsible for GCP regulatory compliance
- Investigators, Study Coordinators and Trial Center Managers who want to learn how to prepare for FDA and sponsor audits and to improve the quality of their research activities
From the following industries: Pharmaceuticals, Biotechnology / Biopharmaceuticals, Drug Discovery & Development, Life Sciences, Contract Research Organisations (CROs) and Hospitals / Research Centers
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PLUS!
Participants will also benefit from exchanging experiences and lessons learnt to further excel in clinical trials auditing, and better learning through lively interactive sessions – brainstorming, exercises and roundtables.
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Course Instructors
Eric Morfin, MBA, PMP, PhD – Founder, BioPharmaPM & Partner, Critical Skills
With over 27 years of leadership and managerial experience in Life Sciences, Eric has led many departments, such as Project Management, QA/QC, Data Management, Operations, Clinical Trials for companies including Merck, Novartis, Pfizer, GSK, Roche, Aventis, BMS, Amylin, the National Cancer Institute, Astrazeneca, the FDA, Quintiles, Parexel, PPD and Genentech.
