Responding to Clinical Trial Inspectional Observations and FDA 483s

Held Nov. 27, 2012

As more aggressive inspections — and warnings — become the “new normal,” it’s vital to know what’s triggering clinical trial citations and what to do if you’re hit with a Form 483.

Inspectors’ findings are usually symptoms of much larger and complex problems.  The FDA is more interested in you performing a full system remediation rather than a band-aid fix.

Here’s where to start.

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The more you know about how to handle 483s, the more power you have to handle things without facing subsequent warning letters, consent decrees … and terminated trials.

Now, FDAnews helps you mount timely, effective response to keep inspection citations from leading to further costly consequences.

To provide expert advice on this critical issue, FDAnews has engaged Darshan Kulkarni — The Kulkarni Law Firm — to help attendees learn how to survive in this tough new climate.

In just 90 minutes, he will provide strategic insights plus industry trends, case studies and ready-to-use advice, including:

  • Latest areas of enforcement action trends with a focus on clinical trials
  • Discussion of what’s triggering warning letters and consent decrees
  • Deciding how to respond to an enforcement action
  • Should you always respond to the findings in an FDA inspection even if you disagree with the FDA?
  • Dissecting the proper and correct anatomy of a response and deciding what to include for the pre-response, response and post-response
  • Conducting the follow-up with the FDA
  • Knowing when to seek outside help
  • Examples of what companies could have done to avoidmistakes others have made
  • And more

Everyone in your organization — from compliance officers and general counsels to site directors and principal investigators — will benefit from the CD/Transcript.

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  • Compliance professionals in clinical trials
  • General/corporate counsel
  • Site coordinators
  • Principal investigators
  • Regulatory/legislative affairs professionals in clinical trials

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm
Dr. Kulkarni focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical, and medical device companies and their service providers, including contract manufacturing organizations and contract research organizations. As corporate counsel for a reputable, international pharmaceutical holding company, he provided corporate and regulatory legal advice to international pharmaceutical, biopharmaceutical and medical device companies. He has had experience in corporate quality control and has worked in varying legal and regulatory areas, including crafting responses to FDA 483s, FDA recalls, and negotiating with and for CROs and sponsors. Dr. Kulkarni has worked as a pharmacist for more than 10 years in multiple settings, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials. He is Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- -Regulatory Considerations.

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