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

Event Details

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

Time: August 3, 2016 from 1pm to 2pm
Location: Online Training
Street: 2754 80th Avenue, New Hyde Park, NY 11040
City/Town: New Hyde Park
Website or Map: http://bit.ly/29wHvOh
Phone: 5169005515
Event Type: fda, form, 483, inspection, warning, letter, audit
Organized By: Compliance Global Inc.
Latest Activity: Aug 7, 2016

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Event Description

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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