Preparing and Executing Medical Device Quality Audits: How to Meet the FDA's Expectations

FACT: The US FDA conducts inspections of medical device manufacturers to determine compliance with quality system and other regulations. FDA inspections are different from audits by Notified Bodies and other certification organizations. The FDA is a law enforcement organization and uses each inspection to gather evidence for enforcement actions. Your organization must be prepared to defend its position with the investigator, and be vigilant against inadvertently placing itself in a position where FDA will take an enforcement action.

This presentation will review the process used by FDA to perform inspections of medical device manufacturers. It will also review the types of inspections that may be conducted and the plan used to inspect a facility. In some cases the FDA will not notify a facility in advance of an inspection, the presentation will discuss those cases, providing tips on how a manufacturer should respond.

Areas Covered in the seminar:

• How does the FDA determine what facilities to inspect.
• How to respond to advance notification of inspection.
• What to do when the inspector arrives if not notified of inspection, and if notified in advance.
• Planning for an inspection from FDA.
• Developing procedures for an FDA inspection.
• What are the different types of inspections and how do you prepare.
• What actions can FDA take as the result of an inspection? How does the manufacturer respond to the inspection report?

Who will benefit:

This webinar is designed to specifically prepare medical device manufacturers for inspection by FDA personnel. The webinar will provide advice for quality and regulatory personnel and any other personnel that may be required to provide information to an FDA inspector.

• Quality Managers
• Regulatory compliance personnel
• Project team leaders and other design team members
• Complaint team members
• CAPA personnel
• Management personnel

Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations. Edwin has over 20 years experience in the medical device industry and has participated in inspections in seven different FDA. He has been in the primary role for both leading the manufacturing team in an inspection and responding to the FDA inspection reports. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training FDA personnel in the Quality System Regulation.

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