COURSE ID 2976

Basic Principles of GCP (Good Clinical Practice)

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

Good Clinical Practice (GCP) standards, required by the FDA and international regulatory bodies, provide assurance that the data and reported results are credible and accurate, and the rights, integrity, and confidentiality of trial subjects are respected and protected.

During this 90-minute, intensive training, participants will obtain a comprehensive overview of the purpose, scope, and legal basis of GCP, the role of important international standards and guidelines versus US law and regulations, and an overview of FDA inspections conducted to assess GCP compliance. A fundamental understanding of GCP is foundational to all personnel who take part in GCPgoverned operations.

This accredited online training is intended for professionals in the Pharmaceutical industry working in the clinical trials area. It will be especially beneficial to the following personnel:

– Clinical Operations staff
– Drug safety personnel
– Clinical Quality Assurance personnel
– Medical writers
– Data Management and Biostatistics personnel
– CRO employees who work on clinical trial engagements

course instructor

David L. Chesney
Principal and General Manager of DL Chesney Consulting

David L. Chesney’s Courses
David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC, Cumberland Foreside, Maine. He founded the company in 2016 following 23 years with the FDA and 21 years as Vice President of Strategic Compliance Consulting Services for a major US-based CRO. He began performing GCP inspections for the FDA as early as 1974. During his FDA career, he advanced from Investigator to Supervisory Investigator, Director of investigations and District Director. He also served as a law and evidence development instructor for FDA new hires. From 1995 to the present, he has consulted for companies worldwide on GCP compliance and remediation of potential violations.

Mr. Chesney holds an MS degree in Jurisprudence from Seton Hall University School of Law and a BA in Biology from California State University, Northridge. He also completed three years postgraduate study in biology at Cal State Northridge and San Diego campuses.

Mr. Chesney is an instructor for the Food and Drug Law Institute’s continuing education programs in drug and biologic law, the Training and Research Institute of the Parenteral Drug Association, and an adjunct lecturer for the Maine Ethics and Regulatory Training Center, University of Maine law school. He is widely published and is a frequent public speaker on FDA enforcement matters.