• Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483 and Warning Letters
  • Learn how to buy COTS software and qualify vendors.
  • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
  • Requirements for local, SaaS, and cloud hosting
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
  • Write test cases that trace to elements of risk management
  • Protect intellectual property and keep electronic records safe
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    21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud Seminar 2018

    Start Date : August 8, 2018
    End Date : August 9, 2018
    Time : 8:30 am to5:00 pm

    Phone : 8004479407
    Email : john.robinson@globalcompliancepanel.com

    Description

    Course “21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

     

    Overview:


    Course Objectives:


    Who will benefit:

    Agenda:

    Day 1 Schedule


    Lecture 1:

    Introduction to the FDA


    Lecture 2:

    21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures


    Lecture 3:

    The Five Keys to COTS Computer System Validation

    Day 2 Schedule


    Lecture 1:

    Ten-Step Process for COTS Risk-Based Computer System Validation


    Lecture 2:

    How to Write Requirements and Specifications


    Lecture 3:

    How to Conduct a Hazard Analysis/Risk Assessment-Exercise


    Lecture 4:

    Software Testing


    Lecture 5:

    System Change Control


    Lecture 6:

    Purchasing COTS Software


    Lecture 7:

    Cost Reduction Without Increasing Regulatory or Business Risk

    Speaker

    David Nettleton

    FDA Compliance Specialist,

    Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation – Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

     

    Location:  Zurich Switzerland Date: August 8th & 9th, 2018 and Time: 8:30 AM to 5:00 PM

    Venue:  Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland

     

    Price:

    Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

    Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*

    Regular Price: $1,895.00

    Sponsorship Program benefits for  seminar

    For More Informationhttps://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

     

     

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia/

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

    Follow us on Twitter: https://twitter.com/GCPanel

     

     

    Registration Info

    Register Now

    Admission :

    Price: $1,895.00 (Seminar Fee for One Delegate)

    Register for 5 attendees Price: $5,685.00 $9,475.00 You Save: $3,790.00 (40%)*

    Register for 10 attendees Price: $10,422.00 $18,950.00 You Save: $8,528.00 (45%)*

     

     

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    Netzealous - GlobalComplianePanel ,
    NetZealous LLC, 161 Mission Falls Lane

    • Understand what is expected in Part 11 and Annex 11 inspections
    • Avoid 483 and Warning Letters
    • Learn how to buy COTS software and qualify vendors.
    • Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
    • Requirements for local, SaaS, and cloud hosting
    • How to select resources and manage validation projects
    • "Right size" change control methods that allows quick and safe system evolution
    • Minimize the validation documentation to reduce costs without increasing regulatory or business risk
    • Write test cases that trace to elements of risk management
    • Protect intellectual property and keep electronic records safe
    Tel: 5105849661
    Mobile: 8004479407
    Email: john.robinson@globalcompliancepanel.com
    Website: https://www.globalcompliancepanel.com/seminar


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