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EVENT DATE
Oct 2017
M T W T F S S
23242526272829
EXPO DATE
Oct 2017
M T W T F S S
23242526272829

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Online Event
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Type: Online Event

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483 Covers A Broad Gradation Of Problems

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EVENT DESCRIPTION

Overview:
How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation.

Why You Should Attend:
Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may quickly lead to an administrative or a legal action that can have an immediate adverse effect on a firm’s business.

Areas Covered in the Session:
What the 483 means
How to interpret the 483 - "How bad is it?"
Managing the 483 discussion with the FDA at the conclusion of the inspection
Responding to the FDA in writing

Who Will Benefit:
Manufacturers
FDA Consultants
Legal Counsel
Regulatory Affairs Managers
Quality Assurance Staff

Speaker Profile:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Not sure if you want to exhibit at or attend the 483 Covers A Broad Gradation Of Problems? See the panels below to get the information you need to make an informed decision.

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EVENT DETAILS

Primary Industry:
Manufacturing - General
Other Industries:
Manufacturing, Manufacturing - General
Audience:
Manufacturers
FDA Consultants
Legal Counsel
Regulatory Affairs Managers
Quality Assurance Staff
Notes:
Show Owner:
Compliance4All DBA NetZealous
Sponsorship:

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Compliance4All DBA NetZealous

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