RESPONDING EFFECTIVELY TO FDA 483 OBSERVATIONS AND WARNING LETTERS

About the Product
Includes 45 minute Windows Media Video File and PowerPoint presentations for immediate download.

Many organizations and executives will at some point be faced with addressing an FDA 483 warning letter focused on quality system deficiencies. The process of responding and taking corrective action as a result of a warning letter is arguably a stressful time within a medical device organization, but must be handled professionally and effectively. Through this presentation, best practices for resolving and preventing 483’s will be shared and the lessons learned throughout the event of an FDA warning letter will be examined.

• Step by step guidance for preparing an effective response to 483s and warning letters
• Identify strategies for avoiding common pitfalls encountered when preparing a response
• Potential implications of failing to submit an effective response

Speaker:
Pamela Forrest
Partner
King & Spalding

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

• Quality Management
• Quality Systems
• Regulatory Affairs

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​