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Clinical Trial FDA Inspection & Audit
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“FDA inspectors are responsible for identifying substandard data and good clinical practice violations at clinical and data management facilities. Doing less jeopardizes public health” (US FDA)
Key Learning Outcomes:
This 2-day course has been designed to benefit those involved in the monitoring and/or QA of clinical trials:
- Understand the GCP audit process for sponsors
- Know when to conduct audits of vendors, sites, IRBs and laboratories
- Understand best practices in preparing and conducting audits
- Ensure that your data and supporting documentation are accurate and presentable for inspection
- Understand the critical skills required to achieve and maintain excellence in auditing practices
- Gain knowledge concerning common outcomes and findings in clinical trials
- Understand how to respond to an audit to avoid further regulatory consequences
- Learn how to detect and prevent fraud and misconduct in clinical trials
- Fully understand the consequences which result when proper procedures are not followed, through the use of examples
- Practice Mock Audits and discuss lessons learned with your peers and the instructor
Who Should Attend
Attendees who work for Pharmaceutical or Biotech firms, Medical Device companies, Contract Research Organizations (CRO), Institutional Review Boards (IRBs) and academic institutions involved with the supervision or oversight of clinical trial practices and quality will find this course to be highly beneficial. It has also been designed for people in the following roles:
- 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
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.
