How to Prepare for and Host an FDA Inspection and Respond to 483's
This webinar covers FDA inspection preparation, response to 483s, warning letters, mock audits, personnel tasks, facility requirements, inspection process, and documentation requirements.
Date:
Wednesday, July 2, 2025
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes
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Product Id : 506979
Price Details
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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, 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 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Handout is 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