22CFR Part 11 Compliance for SaaS/Cloud Applications

22CFR Part 11 Compliance for SaaS/Cloud Applications is a seminar that addresses effective strategies for reducing costs and ensuring compliance in the validation and maintenance of computer systems used in regulated environments.

Topics

• 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

Who should Attend

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