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Aug 2016
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How to prepare for and host a FDA inspection and respond to 483's - By Compliance Global Inc.

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Overview

Overview:

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483 warning letter than a disorganized company.

Why Should You Attend:

If a 483 is received knowing how to respond will lessen chances of receiving the FDA Warning Letter.

Areas Covered in this Webinar

  • FDA audit inspection process
  • Personnel preparation
  • Facility needed to support inspection
  • Behavior during inspection-what not to sign
  • Internal audits
  • Mock audits
  • 483 responses

Learning Objectives:

  • How to prepare personnel
  • How to prepare facility
  • How personnel should conduct themselves
  • How to respond to 483’s

Who Will Benefit:

  • Engineering Personnel
  • QA Personnel
  • Regulatory Managers
  • Manufacturing Management Team
  • Management Professionals

Speaker Profile:

Edwin Waldbusser 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.

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

For more detail please click on this below link:

http://bit.ly/29wHvOh

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

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