Good Clinical Practice (GCP) Basics for GMP Experts

For example, the webinar presents the fundamental legal basis for GCP, which regulations are within the scope of the topic, the objectives and scope of GCP, and how the Quality Assurance role differs between GMP and GCP. Specific directions as to where to find more detailed guidance and help in understanding the requirements is provided via URL links to the FDA, EMA and ICH web sites containing published guidance for the field.

Particularly in the startup or virtual company setting, staffing levels may not always permit dedicated support of both the GMP and GCP quality units. As a result, many experienced GMP quality managers find themselves confronted with the need to also manage GCP quality and compliance. This can be difficult at times, since the language, terminology, issues encountered and event the lawful authority of the quality unit in GCP is different in key respects from what it is in the GMP area. This can lead to confusion, frustration and sometimes even conflict unless a fundamental understanding of the requirements and their purpose is instilled. This webinar is intended to answer the types of questions commonly asked by GMP-knowledgeable personnel when they initially enter the GCP environment, serving to facilitate their ability to manage in both quality and compliance areas.

• Definition and origin of GCP
• Which FDA regulations together form the scope of GCP
• FDA authority and the legal basis of GCP
• Requirements for Sponsors of clinical trials
• Requirements for clinical trial sites
• Role of Contract Research Organizations
• Similarities and differences between GMP and GCP
• Directions for where to find key FDA, EMA and industry (ICH) guidance documents with selected URL links provided

• Executive leadership team
• VP/Director of Clinical Quality Assurance
• Clinical QA personnel
• Anyone with GMP background seeking a deeper understanding of GCP
• Quality Auditors

Instructor Profile:

David L. Chesney

Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney has a combination of 52 years experience, 23 with the FDA in an inspection and enforcement capacity, followed by over 29 years consulting experience with pharmaceutical and medical device companies world wide. He is an experienced and accomplished instructor and public speaker.

He has served as an expert witness in several private litigation matters as well as FDA court cases while with the agency. Mr. Chesney holds a BA degree in biology from California State University Northridge and an MS in Jurisprudence (pharmaceutical and medical device law) and a certificate in health care compliance from Seton Hall University School of Law.