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    FDA's 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel

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    Website http://bit.ly/12ZDGHX | Want to Edit it Edit Freely

    Category Webinar, Health, Medical, Pharma, Clinical

    Deadline: June 20, 2013 | Date: June 20, 2013

    Venue/Country: Fremont,CA, U.S.A

    Updated: 2013-05-29 14:01:32 (GMT+9)

    Call For Papers - CFP

    Overview: 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 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 you should 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. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.

    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?

    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

    Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

    etZealous LLC,

    DBA GlobalCompliancePanel

    161 Mission Falls Lane,

    Suite 216, Fremont, CA 94539, USA

    USA Phone:800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    Event Link - http://bit.ly/12ZDGHX

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.