IN DECEMBER THE FDA BEGAN A PROJECT TO BETTER 2013 - Live webinar on 21 CFR Part 11 Add-On Inspections By the FDA

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Category Medical Device

Deadline: February 11, 2013 | Date: February 12, 2013-February 14, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 18:04:19 (GMT+9)

Call For Papers - CFP

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?

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

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 and has almost 30 years experience in Life Science. She applied for a patent to speed up computer systems validation and FDA software audits in the life sciences industry which was approved in June 2012. She has co-authored “Computerized Systems in Clinical Research” with the FDA, DIA and Academia and teaches classes in Project Management, 21 CFR 11, Computer Systems Validation (CSV), Quality Assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to the Life Sciences industry.

Ms. Bazigos has worked in various capacities at Roche, Price Waterhouse Coopers, Incyte Genomics, Abgenix, Novartis, Chiron, Applied Biosystems, Clinimetrics, and Veracyte, respectively. More recently, Ms. Bazigos was recognized as an industry subject-matter expert by the FDA and DIA. Ms. Bazigos graduated from North Staffordshire University (England, UK) with an MSc in Computing and University of Reading (England, UK) with a BSc in Microbiology & Biochemistry.

Speaker : Angela Bazigos

Product ID : F62188

Schedule Date :

Tuesday, February 12, 2013

duration : 01:00 to 02:30 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=56