Sign for Notice Everyday    Sign Up| Sign In| Link| English|
Home Post Event 2025Event 2026Event By Topic By Country Contact

Our Sponsors


    COURSE "PROJECT MANAGEMENT FOR COMPUTER SYSTEMS VA 2013 - Project Management for Computer Systems Validation - Webinar By GlobalCompliancePanel

    View: 212

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

    Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

    Deadline: March 14, 2013 | Date: March 14, 2013

    Venue/Country: California, U.S.A

    Updated: 2013-03-11 19:09:34 (GMT+9)

    Call For Papers - CFP

    Overview: Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.

    This class, will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

    Areas Covered in the Session:

    FDA Inspections - background

    Causes of Form 483 / Warning Letter

    Some recent results of companies failing to respond appropriately

    Best Practices for Responding to 483

    Best Practices for Responding to Warning Letter

    What to do if the responses fail

    Who Will Benefit:

    Project Managers

    IT Management

    Business Process Owners

    Quality Managers

    Quality Engineers

    GxP

    Consultants

    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.

    USA

    GlobalCompliancePanel,

    Livermore Common, Fremont, CA, 94539

    USA Phone:800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    http://bit.ly/ZpaZRu

    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.