Dealing with FDA is never easy, but two of the most disconcerting times for medical device companies are when an FDA investigator issues a List of Observations (the FDA483) at the conclusion of an inspection, and when you receive a letter from FDA by certified mail that has "Warning Letter" written at the top.

Now what do you do? The 483 never says you must reply either verbally or in writing, but the warning letter states that you must respond to FDA concerns in writing within 15 days. How do you respond to the 483 and/or the warning letter? Does it make a difference in how you make your response? Who reads your response and what effect does a good response have on FDA's next regulatory step? Join us as device consultant and former FDA supervisor Alan Schwartz provides the answers.

This audio conference covers:

• How to look at the 483 observations in preparing your response
• The differences in preparing your response to the 483 and the warning letter
• What the timeframe should be for making your responses
• How to prepare the response and what are you trying to achieve
• What to do if you disagree with a 483 observation

About the speaker:

Alan Schwartz Executive VP of mdi Consultants, Inc., Great Neck, NY was a former US FDA supervisor of field investigations for the NY District Office. He has been consulting to the medical device industry since 1978 and has audited over 800 companies worldwide.

He is recognized as the third party expert by the FDA for bring companies with warning letters and injunctions into compliance. He has assisted numerous companies to understand the FDA regulatory process, dealing with FDA inspections, responding to 483s and warning letters. He has given seminars on FDA regulations and compliance worldwide.

Who should attend?

• Quality assurance
• Quality control
• Regulatory affairs
• Senior management

This audio conference is rated General Interest.