Overview:
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
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 you should 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