Live Webinar On 21 Cfr Part 11 Add-on Inspections By The Fda By Compliance2go

Why should you Attend:

Why should you Attend:

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections.

At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar 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.

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?

- What are the most frequent deviations for computer system validation?

- Under which circumstances can inspectors exercise enforcement discretion?

- How important is risk based Part11 compliance?

- What is the best strategy for future proven Part 11 compliance?

Who will Benefit:

* Everybody using computers in FDA regulated environments

* IT manager and staff

* QA managers and personnel

* Regulatory affairs

* Training departments

* Consultants

* Validation specialists

About Speaker

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia

Thursday, December 15, 2011

01:00 to 02:30 PM EST

Discount : Get 15 % Discount as a Thanks Giving. Use Promo code CGO15

by: Compliance2go

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