The FDA Inspection Process: From SOP to 483
Jeff Kasoff Overview:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Why you should Attend:
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Areas Covered in the Session:
- Types of Inspections
- Preparation
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal audits
- SOP for inspections
- Behavior during inspection: What to say and do, and what NOT to say and do
- Inspection process
- How and when to craft a written response
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Internal Auditors
- Compliance Officers
- Executive Management
- Managers/Directors/Supervisors and Personnel related to:
- Regulatory Compliance and Regulatory Affairs
- Quality Management System
- Quality Assurance
- Product Development
- Engineering
- Manufacturing
- Complaint Handling
- Personnel new to regulated industry
- Training personnel
- Document Control Personnel
Speaker Profile
Jeff Kasoff RAC, CMQ/OE, LBB, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of companies, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.