FDA Bioresearch Monitoring Inspection Program 2024

The webinar will explain the scope of FDA inspection focus in each of these areas, the objectives of each, types of questions normally asked, documents typically reviewed, and specific direction to obtain copies of the relevant programs from the FDA web site.

The webinar will also present a recap of the most common inspection observations (potential violations) noted for each category of inspection, and will offer tips for inspection readiness, management and post-inspection communication with the FDA.

By policy, FDA pre-announces the great majority of its inspections in the bioresearch monitoring area. When companies receive such notification, the time prior to onset of the inspection is normally short, leaving little time for advance preparation. Therefore it is prudent for companies to amass the necessary understanding of the programs well ahead of experiencing an inspection. Doing so will help to minimize anxiety and reduce the chance of miscommunication or misunderstanding during the inspection. It will also help to assure that any observations made during the inspection are promptly and effectively answered within the expected time frame after conclusion of the inspection.

• FDA inspection authority
• Scope of the bioresearch monitoring programs
• Steps in the progression of an inspection
• Regulatory and business imperative for advance preparation and readiness
• What to expect during the inspection
• Where to obtain detailed information to aid in preparation, in advance
• Common inspection observations noted
• Effective outline for responding to any observations in writing

• Executive leadership team
• Clinical Operations
• Clinical Quality Assurance
• Drug safety (pharmacovigilance)
• Medical Monitor
• Data Management
• Clinical Research Associates (site monitors)
• Quality Assurance 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.