Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR  

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Seminar Summary:

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. (see full course description)

 

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Training Course Syllabus:


Learning Objective:



  • Reduce costs, usually by two-thirds, for compliance with electronic records

  • Learn how to use electronic records and electronic signatures to maximize productivity

  • Understand what is expected in Part 11 and Annex 11 inspections so you are prepared

  • Avoid 483 and Warning Letters

  • Understand the responsibilities and specific duties of your staff including IT and QA

  • Understand your responsibilities and liabilities when using SaaS/cloud

  • Learn how HIPAA expands Part 11 compliance

  • Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates

  • How to select resources and manage validation projects

  • "Right size" change control methods that allows quick and safe system evolution

  • Minimize validation documentation to reduce costs without increasing regulatory or business risk

  • Learn how to reduce testing time and write test cases that trace to elements of risk management

  • Learn how to comply with the requirements for data privacy

  • Learn how to buy COTS software and qualify vendors

  • Protect intellectual property and keep electronic records safe


Seminar Summary:

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. (see full course description)

print this agenda print agenda for the Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR training seminar

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