Live Webinar on FDA Inspection Preparation Guide: Handling 483s and Warning Letters
OVERVIEW
In
this webinar 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 responding to 483s and FDA warning letter.
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
is required to conduct an inspection every two years. A company that is
prepared for FDA audits 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 an FDA warning letter.
AREAS
COVERED
- Personnel
preparation
- Procedure
to follow during FDA audits - what to do/ what not to do
- Facility
requirements to support FDA inspection
- Behavior
during inspection-what not to sign
- Internal/
mock audits
- 483s/
FDA Warning Letter response
LEARNING
OBJECTIVES
Learn
how to be always prepared for FDA inspections and how to handle 483s and FDA
warning letter. Also understand the significance of mock audits.
WHO
WILL BENEFIT
- Engineering
personnel
- Engineering
management
- Quality/
regulatory Management
- Corporate
Management
- Manufacturing
Management
- Division
management
- Legal
counsel
Use
Promo Code MKT10N and get flat 10% discount on all purchases
For more detail please click on this below
link:
https://bit.ly/2Nn7MSJ
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