RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Utah Chapter Webcast: Legal Aspects of FDA Regulatory Compliance: Preparing for an FDA Facility Inspection and Responding to a 483 Letter

1.0
RAC Credits
Tuesday, 16 June 2020 (12:00 PM) - Tuesday, 16 June 2020 (1:00 PM) Mountain Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

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. 

The key to a successful inspection strategy is adequate preparation and implementing the inspection plan before FDA knocks on your door. 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. 

Attendees will learn:

  • What to expect during the inspection;
  • Strategies for preparing for an inspection;
  • What to expect after the inspection;
  • Strategies for responding to any deficiencies noted in a 483 report;
  • Potential product liability issues stemming from a 483 report.

There will be a Q&A session at the end. 

This event is brought to you by the RAPS Utah chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. Registration will close 48 hours prior to the event. 

Featured Speakers:
Kristy M. Kimball, partner, Holland & Hart, LLP
Brent Johnson, partner, Holland & Hart, LLP
Lee Gray, partner, Holland & Hart, LLP

Register