Live webinar on FDA's 21 CFR Part 11 Add-on Inspections

Top Quote 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. 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. End Quote
  • (1888PressRelease) July 26, 2014 - In December 2010 the FDA began a project to better understand the industry's adherence (or lack thereof) to 21 CFR Part 11. This involves the add on' surveillance inspections of the sponsors' computer systems during the course of the FDA's regular inspections.

    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:

    - Quality Managers
    - Quality Engineers
    - Small business owners
    - GxP
    - Regulatory Affairs professionals
    - Consultants
    - Quality VPs
    - IT VPs
    - Regulatory VP
    - CEOs

    Price Tags:

    - Live
    Single Live : For One Participant = $ 249
    Corporate Live : For Max. 10 Participants = $ 899

    Recording

    - Single REC : For One Participant - Unlimited Access for 6 Months = $ 299

    For more information and enquiries contact us at
    Compliance Trainings
    5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
    Customer Support : 416-915-4458
    Email : support ( @ ) compliancetrainings dot com

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