FDA MEDICAL DEVICE
INSPECTIONS

Conference Date: 23-24 Apr 2009
Conference Ref: N4-8109
Fee: £1100 + VAT
Venue: The Rembrandt Hotel, London

Benefits of Attending:

• Clarify the Recent Changes in FDA’s Compliance Policy
• Understand FDA’s Risk Based Approach to Medical Device Inspections
• Gain an Overview of QSIT (Quality System Inspection Technique) including FDA Focus Areas
• Receive Practical Guidance on How to Prepare for an FDA Inspection
• Discuss Common Pitfalls .… and How to Overcome Them
• Discover FDA Inspection Trends
• Know How to Respond to FDA 483s, Warning Letters

If you currently manufacture or are planning to manufacture medical devices for sale in the United States (US), your company will be inspected by the US Food and Drug Administration (FDA). During this comprehensive two day seminar, a Quality Management System expert will discuss the FDA inspection process.
Specifically; how to prepare for the inspection, what to do when the investigator is in your facility and what to do after the investigator leaves. 

There will be ample time for questions and discussion during the two days