21 CFR 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
