Overview: In this presentation, we will review recent medical device manufacturers Warning Letters to determine the inadequacies of responses by manufacturers.
After finding the weaknesses in the responses, we will identify those characteristics of an adequate response by manufacturers to avoid a Warning Letter and additional enforcement actions by FDA. All medical device companies preparing for FDA inspections should review the information in this presentation and prepare a plan for response to an FDA-483 before the FDA arrives. There will be insufficient time to react during an inspection and after an FDA investigator leaves a FDA Form 483 to develop a response without prior preparation.
Why you should attend: Some of the Warning Letters issued by FDA are issued because the manufacturer has failed to respond to inspection observations (FDA-483) in a timely manner or without sufficient information or with weak responses. The number of Warning Letters issued in 2010 is much greater than those issued in earlier years. Medical device manufacturers can reduce the possibilities of receiving Warning Letters with timely adequate responses.
Areas Covered In the Seminar: - Review actual medical device Warning Letters
- Identify common weaknesses that lead to Warning Letters
- Lack of timely response
- Lack of sufficient information
- Appearance that manufacturer is not serious about responsibilities
- Prepare for inspection response
- Develop FDA 483 Response Plan
- Assign responsibilities
Who will benefit: - Regulatory Management
- Quality Management
- Quality Engineers
- Internal Auditors
- Company senior management
