21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • 2025

Description

21 CFR Part 11 Compliance for SaaS/Cloud Applications is a seminar that covers topics such as:

  • Reducing costs, usually by two-thirds, for compliance with electronic records
  • How to use electronic records and electronic signatures to maximize productivity
  • What is expected in Part 11 and Annex 11 inspections so you are prepared
  • Avoid 483 and Warning Letters
  • The responsibilities and specific duties of your staff including IT and QA
  • Responsibilities and liabilities when using SaaS/cloud
  • How HIPAA expands Part 11 compliance
  • 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
  • Minimizing validation documentation to reduce costs without increasing regulatory or business risk
  • How to reduce testing time and write test cases that trace to elements of risk management
  • How to comply with the requirements for data privacy
  • How to buy COTS software and qualify vendors
  • Intellectual property and electronic records safety

21 CFR Part 11 Compliance for SaaS/Cloud Applications brings together attendees from health care, clinical trial, biopharmaceutical, and medical device sectors, including:

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

21 CFR Part 11 Compliance for SaaS/Cloud Applications might be held in 2025.

More Details

Prices:
1499-1899 US Dollar (Estimated)
Exhibition:
No exhibition
Organizer:
ComplianceOnline
Website:

Future Events

Past Events

Important

Please, check "21 CFR Part 11 Compliance for SaaS/Cloud Applications" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Technology: Information Technology (IT), Software & Applications

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