Managing your fda 483

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Live Webinar Managing your FDA 483 - Your Pandora's Box Date: Wed, December 10, 2014 Instructor: Casper Uldriks

Time: 10:00 AM PST | 01:00 PM EST Location: Online

Duration: 60 Minutes

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Overview: The FDA Form 483 represents an inspectional record of objectionable conditions observed by the FDA investigator during an inspection of a manufacturing establishment. The inspection will cover a certain set of regulations that apply to the particular manufacturer's operations. Products regulated by FDA have different manufacturing, records and reporting regulations.

Areas covered in the session: What is a 483 besides another government form? How and when the 483 is written How to effectively manage 483 items during an inspection How to interpret the 483 How to respond verbally and in writing to FDA FDA's follow up inspection

Who Will Benefit: Regulatory Affairs Quality Assurance Manufacturing Complaint evaluation Public Relations and Sales

About Speaker Casper Uldriks ex-FDA Expert and former Associate Center Director of CDRH, Olsson Casper Uldriks 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

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