The Infamous Form FDA 483: How you respond can make or break you

Duration: 60 Minutes
flat 40% off on this webinar use promo code
The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
Form FDA 483
Instructor: Casper E Uldriks
Product ID: 500088
The issuance of a 483 by the CSO at the conclusion of an inspection will be discussed with the establishment's management and put them on notice that the nonconformities warrant correction and that a failure to do so may result in further action by the FDA, such as civil money penalties, seizure, injunction, and/or prosecution. Firm's are well advised to take the warning seriously.

Prior to an inspection, the CSO will review prior 483s issued to the establishment and the responses previously made by the firm concerning promised corrections. You will be held accountable for your prior response. What you promise and what you do, or don't do, become critical factors in the FDA's assessment of a firm's capacity to operate in compliance with the FDA's applicable requirements. A failure to establish and implement a corrective action to prevent prior deficiencies reflects poorly on the firm's management. The FDA will hold the firm's management accountable for its failure to adequately correct its regulatory problems. In some cases, the FDA will hold senior management personally liable for their managerial actions or inaction. Again, what a firm promises and what a firm does in response to a 483 makes a difference. It creates a body of proof that may set the basis for legal action by the FDA.

Objectives of the Presentation:
  • What the Form FDA "483" means
  • How to manage the FDA's 483 observations during and after an inspection
  • What the FDA considers important
  • How to respond effectively to 483 observations
  • Plan for the wake of problems generated by a 483
  • Learn how to restore, or destroy, your regulatory profile with the FDA
Who can Benefit:
  • Senior Operations and Finance Executives
  • Regulatory Affairs Professionals
  • In-house Legal Counsel
  • Senior Managers for Manufacturing and Quality Assurance
  • FDA Consultants
  • Public Relations Professionals
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
View More