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
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