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Key deadlines

Conference starts:

2018-03-07

Website

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Conference Description

Overview:
This presentation will cover the scope, status and results of the

surveillance inspections and what they may mean for the future of 21

CFR Part 11. This will enable you to determine whether your company

is subject to the most common violations so you can take action to

have a better inspection outcome.

Why should you Attend:
In December 2010 the FDA changed the way it does audits to include

21 CFR 11 add-on inspections. Very little is known about this, yet the

FDA has already issued citations on the subject.

Areas Covered In the Session:
What is FDA's most current thinking related to computers and

electronic records?
What are the inspection trends?
What are most frequent recent citations for Part11?

Who Will Benefit:
Everybody using computers in FDA Regulated Environments
IT Manager and Staff
QA Managers and Personnel
Regulatory Affairs

Speaker Profile:
Angela Bazigos Seasoned Executive with 40 years of experience in the

Life Sciences & Healthcare Industries. Positions include Chief

Compliance Officer. Experience combines Quality Assurance,

Regulatory Compliance, Business Administration, Information

Technology, Project Management, Clinical Lab Science, Turnarounds

and Business Development.

Event Fee: One Dial-in One Attendee Price: US$150.00

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