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

 
  February 12, 2025  
     
 
ComplianceOnline, Online Seminar
2025-03-05


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.

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

 

 
 
Organized by: ComplianceOnline
Invited Speakers: David Nettleton, FDA Compliance Specialist, Computer System Validation
 
Deadline for Abstracts: 28-02-2025
 
Registration: https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=hum-molgen
E-mail: referral@complianceonline.com
 
   
 
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