Live Webinar on : 21 CFR Part 11 Add-On Inspections by the FDA

Tuesday, July 10, 2012 duration

: 10:30 to 12:00 PM EDT

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. Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

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.

Pricing

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..

Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Get Training CD : $449 Play back(Unlimited views):-309

Areas Covered in the Session: What is FDA's most current thinking related to computers and electronic records?

Who will benefit: (Titles)

* Everybody using computers in FDA regulated environments * IT manager and staff * QA managers and personnel * Regulatory affairs * Training departments * Consultants * Validation specialists
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- 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?
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.About Speaker

Angela Bazigos has been accepted into the prestigious ranks of Stanford Whos Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. Your Passport to Compliance. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits. Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediations following action by the FDA. She also teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeleys Haas Business School for Executive Education in Life Sciences.

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