How to Prepare for a FDA inspection and prepare response to 483's and warning letters.


Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical En........

Overview

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated 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, the inspection process and how to respond to 483's and warning letters.

Why should you attend this webinar?

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.

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHC0004

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Duration: 60 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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