Reducing Regulatory and Liability Risks by Preparing for an FDA Facility Inspection and Responding to a 483 Letter
Program Number
Program Date
CLE Credits
In addition to evaluating data from adverse event reports, the bulk of FDA's regulatory enforcement comes from its facility inspections and resulting 483 reports. Such regulatory enforcement actions not only carry financial risks of regulatory non-compliance, but can also directly impact product liability risks as well. This practical webinar will cover numerous aspects of preparing your drug or medical device establishment for a successful FDA facility inspection and responding to any post-inspection 483 letters. The key to a successful inspection strategy is adequate preparation and implementing the inspection plan before FDA knocks on your door. Attendees will learn: Potential product liability issues stemming from a 483 report; What to expect during the inspection; Strategies for preparing for an inspection; What to expect after the inspection; and *Strategies for responding to any deficiencies noted in a 483 report
Available in States
- California
- Georgia
- New Jersey
- New York
- Texas Self Study
Program Categories
- Biotechnology & Life Sciences
- Business Organizations & Contracts
- Constitutional Law
- Dispute Resolution
- Federal Courts
- Health Care Law
- Pharmaceutical Law
- Regulatory and Administrative Law
PROGRAM CREDITS
- Areas of Professional Practice : 1 Credit
