You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, and how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters.
How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
Why should you Attend
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years.
A company that is prepared for the inspection is less likely to receive 483s than a disorganized company. If a 483 is received knowing how to respond will lessen the chances of receiving a Warning Letter.
The handout is an inspection readiness checklist
Areas Covered in the Session
- Personnel Preparation
- Procedure to follow during audit-what to do/ what not to do
- Facility Requirements to Support Inspection
- Behavior during inspection-what not to sign
- Internal/ Mock Audits
- 483/ Warning Letter response
Who Will Benefit
- Engineering Personnel
- Engineering Management
- Quality/ Regulatory Management
- Corporate Management
- Manufacturing Management
- Division Management
- Legal Counsel
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.