Surviving a FDA GCP Inspection – Preparation Techniques for Success
A Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trial. FDA requirements regarding GCP and related inspections have been around for decades. Despite this, GCP deficiencies are still a major reason for FDA rejection of clinical study data or other regulatory action. Often, simple proactive steps can be taken to strengthen your GCP program and help you survive these inspections. This interactive, 90-minute online course will provide you with the tools to safeguard against inspection deficiencies and satisfy regulatory agencies that your efforts are compliant.
By attending this course, you will learn:
- Tips and tricks to prepare for – and survive – a FDA GCP inspection
- The top issues inspectors see…and how to avoid them
- Knowledge of the most common outcomes and findings
- How to detect problems and deal with them before the inspection
- How to respond to inspection findings and avoid further regulatory action
- Communicating with the FDA – what to say, when to say it, and when to say nothing
This course will be of particular benefit to anyone involved in a management, support, or conduct of a clinical trial in the life sciences. Additionally, this course is extremely useful for both sponsor and vendor companies (e.g. Contract Research Organizations) who need an understanding of the GCP inspection process.
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a regulatory affairs/clinical research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research and regulatory affairs for over 30 years. His is a leading expert in GMP/GLP/GCP compliance and inspection readiness and remediation, having conducted audits around the world at manufacturing facilities, clinical sites, CROs, vendors, laboratories and IRBs. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked at the National Institutes of Health and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration.
Dr. Hamrell has extensive experience in all aspects of product development, GMP compliance and audits in multiple areas: compliance activities; training; vendor and facility audits and compliance remediation, and strategic planning for product development. He has dealt with Regulatory Authorities and inspections in numerous countries and conducted and supervised all aspects of compliance audits and follow-up.