Responding to Clinical Trial Inspectional Observations and FDA 483s
Product Details
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.
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.