Recent Updates of FDA 21 CFR 11 Add-On Inspections

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: [email protected]

Others Details

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