03/11/2019 10:00 AM
Training Topic: FDA Inspection: From SOP to 483
Instructor: Jeff Kasoff
Objectives of the Presentation
- How to prepare for an FDA inspection
- Development and contents of an SOP for FDA inspection
- Personnel training before inspection
- How to behave during an inspection
- Limitations of the scope of an inspection
- Response to investigation findings
- FDA guidance documents used by their inspectors
Why Should you Attend
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you are in charge of compliance, usually in the background and now you are 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! 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.
Who will Benefit
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Executive/senior management
- Regulatory management
- QA management
- Any person who may have direct interaction with FDA officials
- Consultants
- Quality system auditors
- Quality Engineers
- Compliance Specialists
- Compliance Leaders
- CAPA Specialists
- Management Representatives
- Compliance Managers and Directors
- Quality Managers and Directors
- Consultants and Contractors