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    Validation and 21 CFR Part 11 Compliance of Computer Systems

    Start Date : October 4, 2018
    End Date : October 5, 2018
    Time : 9:00 am to6:00 pm

    Phone : (800) 447-9407
    Email : globalcompliancepanel@gmail.com

    Location :
    DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

    Website

    Description



    Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


    Description:


    The Problem


    We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:



    I often refer to 21 CFR 11 and CSV as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement CSV, it is very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up computer validation inspections and the number of citations on the subject are skyrocketing!


    This course is appropriate for the beginner and the experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.


    This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.




    The Seminar


    This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with Computer Systems Validation as follows:



    1. What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented

    2. How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?

    3. Data Integrity Frequently Asked Questions

    4. Validation Master Plan

    5. Risk Based Assessment

    6. Complete Validation for a System (software development lifecycle)

    7. Equipment Qualification

    8. Infrastructure Requirements

    9. Change Control

    10. SOPs




    Who Should Attend:





    Industries:



    Agenda:


    Lecture 1: 
    21 CFR 11 & Annex 11





    Lecture 2: 
    Data Integrity





    Lecture 3: 
    Risk Assessment & Vendor Audits





    Lecture 4: 
    Requirements



     Day 2 Schedule




    Lecture 5: 
    Design





    Lecture 6: 
    Verification & Testing





    Lecture 7: 
    Special Topics





    Lecture 8: 
    Change Control & SOPs





    Lecture 6:


    Conclusions / Wrap-Up


    Speaker:


    Angela Bazigos


    CEO, Touchstone Technologies Silicon Valley

    Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer 
    http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.


     


    Location:  Philadelphia, PA Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM


    Venue:  DoubleTree by Hilton Philadelphia Airport   4509 Island Avenue, Philadelphia, PA 19153


     


    Price:


    Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


    Register now and save $200. (Early Bird)


    Sponsorship Program benefits for seminar


    For More Information- https://www.globalcompliancepanel.com/control/sponsorship


    Contact us today!


    NetZealous LLC DBA GlobalCompliancePanel


    john.robinson@globalcompliancepanel.com


    Toll free: +1-800-447-9407


    Phone: +1-510-584-9661


     Website: http://www.globalcompliancepanel.com


     


    Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901858SEMINAR?seo


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    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/


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    Registration Info

    https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901858SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

    GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/


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