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 HIPAA expands Part 11 compliance
- 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, hosting providers
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