FDA Inspections of Medical Device Sponsors Strategies for Compliance

Held Aug. 12, 2008

Medical device sponsors of clinical research received the unwelcome news of the increase in violations from the Center for Devices and Radiological Health’s (CDRH) division of Bioresearch Monitoring (BIMO).

Is this just a coincidence or is it an indication of tough new standards of conduct for clinical trials? Check out the FDA’s website for the current fiscal year and you’ll find out!

What strategies can you take to ensure compliance at your next inspection?

Carl Anderson, senior consultant, Biologics Consulting Group, will discuss the specific violations that FDA field investigators are currently citing on Form 483s, inspectional observations and warning letters to medical device sponsors. He’ll detail the proactive steps you can take to ensure a deficiency-free inspection.

Order now to listen in and discover:

  • The seven most-cited violations during FDA inspections of medical device sponsors
  • The five basic recommendations from FDA managers to avoid Form 483s
  • What violation has entered FDA’s “Top 5” list for the first time
  • A simple tool that documents compliance with FDA sponsor requirements that can be used to prepare both sponsors and clinical investigators for successful FDA inspections

This audio CD/Transcript is a must for CROs, drug and biotechnology companies conducting pivotal Phase II trials of their first product, and positions in medical device companies sponsoring clinical research, including:

  • Clinical operations
  • Quality assurance
  • Regulatory affairs
  • Data management
  • Senior management
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Carl Anderson, senior consultant, Biologics Consulting Group, is a Tacoma, WA based regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. From 1987 to 2005 he worked for the FDA, specializing in conducting inspections in the BIMO program for sponsors of clinical research, clinical investigators, institutional review boards and nonclinical laboratories. Carl was on the FDA’s international inspection cadre and has conducted audits and inspections in Canada, Europe, the Middle East and East Asia.

Since leaving the FDA, he assists sponsors of FDA-regulated research develop GCP- compliant quality systems. Carl conducts vendor qualification audits, clinical site audits and audits for sponsor responsibilities. He specializes in conducting “mock FDA” audits to assist in inspection preparedness. Carl has made frequent public presentations on good clinical practice, quality assurance and FDA regulations to professional and industry organizations, including the Society of Quality Assurance, Drug Information Association, Regulatory Affairs Professional Society and Association for Clinical Research Professionals. He also conducts training for private industry as well as public agencies, such as the Centers for Disease Control and Prevention and university extension services.

Order now!