Managing FDA Inspections from Readiness through Follow Up Responses

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions (15 Minutes)

1. Brief Background and History of FDA (45 Minutes)
• Brief history of FDA
• Regulatory references
• Terminology
2. The Law (30 Minutes)
• What is the law?
• What are the regulations?
• What gives FDA the right to inspect?
3. Why Is FDA Inspecting Us? (30 Minutes)
• Types of facilities within scope
• Exempt facilities
• Reasons for inspections
4. Who are the Inspectors? (1 Hour)
• An individual or a team?
• The typical investigator “Specs”
• The mind of an investigator
• The inspector’s goals
5. Preparing for an Inspection (1.5 Hours)
• Essential documentation collection
• The SOP
• Mock inspection
6. Managing the Inspection (2 Hours)
• FDA is here!
• What to ask
• What to tell
• Tours
• How to manage documentation requests
• Diffusing situations
• Closeout
7. Potential Outcomes of an Inspection (1 Hour)
• 483s
• Warning letters
• Consent decrees
8. Responding to 483s and Warning Letters (1.5 Hours)
• The Concept
• To whom to send the written response
• Format
• Commitment
• CAPA concept
• Supporting documentation
• Sample 483 responses
9. Post Response Activities (30 Minutes)
• Additional correspondence
• Meetings with FDA
• Verification activities
10. Day 1 Closing Comments and Questions (30 Minutes)

Welcome and Day 1 Reinforcement (15 Minutes)

11. Practical Application # 1 – Practical Exam (1 Hour)
12. Practical Application # 2 – 483 Response (2 Hours)
13. Closing Comments (15 Minutes)
14. Individual/Open Q&A Session (30 Minutes)

Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.