How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

Live Webinar on

How FDA Trains its Investigators to Review CAPA and What You
Should Do to Prepare
Date & Time:


Wednesday, August 10, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: Jeff Kasoff
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Jeff Kasoff
This webinar will provide valuable assistance to all companies that
Director of Regulatory
market in the U.S., since they are by definition subject to FDA
Affairs, Life-Tech, Inc
regulation, in the Medical Device, Diagnostic, Pharmaceutical, and
Biologics fields.
Jeff Kasoff, RAC, is the Director of

Quality at Byrne Medical, a leading
This session will discuss what the FDA tells their inspectors, and how
manufacturer of endoscopy
they train them, including a detailed analysis of the CAPA training.
products. In this position, Jeff is
responsible for supplier
Also contained in this session will be a section-by-section summary of
management, during which he
the QSIT, the document by which FDA inspectors operate during an
reviews and approves supplier
inspection, as well as how your company can use that same
qualification, selection, assessment,
document in your preparation.
and CAPA. Prior to this, Jeff spent 13

years at Life-Tech as the Director of
Regulatory Affairs, where he was
Why you should attend:
responsible for regulatory

compliance of all aspects of the
What should I expect the FDA investigator to look at when they visit?
quality system. Jeff received his
The FDA inspection can be much easier to handle and manage if you
regulatory affairs certification in
know what to expect. Advance knowledge will enable you to prepare
1996. ...more
for the FDA inspection. This knowledge and planning will make the
inspection experience much less stressful, and assure better
compliance.

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Your Necessity is our Priority
Areas Covered in the Session:
l
How to prepare for an FDA inspection?
l
Development and contents of an SOP for FDA inspection.

l
Reliance of FDA inspectors on compliance program guide
manuals.
l
Reliance of FDA inspectors on other external sources.
l
Personnel training before inspection.
l
In depth review and summary of QSIT.
l
Use of QSIT for internal auditing.
Click here to register for this webinar
Who Will Benefit:

The employees who will benefit include:
l
Executive/Senior Management
l
Regulatory Management
l
QA Management
l
Any personnel who may have direct interaction with FDA
officials
l
Consultants
l
Quality System Auditors
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel
About GlobalCompliancePanel
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