How to Manage an FDA Inspection

What happens when the FDA investigator arrives at your facility? What questions will be asked? What are the common mistakes that you can avoid? This webinar is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection. The program is designed for the medical device, IVD, and combination product industries.

Areas Covered in the seminar:

• Background (FDA Authority)
• Notification Process
• Inspection Preparation
• Arrival & Opening Meeting
• The Inspection
• Closing Meeting
• Follow-up Activities

Who Will Benefit:

• Senior Executive Management
• Quality Assurance / Quality Systems
• Compliance Managers and Professionals
• Auditing
• Regulatory Affairs
• Operations
• Engineering

Instructor Profile:

Susan C. Reilly, Principal for Reilly & Associates, has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.
Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor.

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