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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Presented By ComplianceOnline
Wednesday, August 4th at 8:00am PST
Online sale ends: 08/04/21 at 7:00am PST
online event
6201 America Center Drive Suite 240 San Jose, CA 95002, USA
San Jose, CA 95002
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Learning Objectives:

  • 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 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

    Who will Benefit:

    • GMP, GCP, GLP, regulatory professionals
    • QA/QC
    • IT
    • Auditors
    • Managers and directors
    • Software vendors, SaaS hosting providers

Presented By

8:00am to 2:00pm
Doors open at 8:00am

General Admission: $1.00

All Ages

online event<br> 6201 America Center Drive Suite 240 San Jose, CA 95002, USA<br> San Jose, 95002


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