CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Call for Papers
- U.S. FDA's expectations / requirements
- Recent Data Integrity and Cybersecurity regulatory requirements
- Roles of Verification and Validation; Legal requirements; Recommended “best practices”
- The development of a 21-year long, field-tested FDA "Model"
- Basic development, implementation, use, and decommissioning expectations
- 21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
- Expected Regulatory Deliverables
- Applicable standards and industry-recommended Guidelines
- Senior and middle management
- Software engineering
- Sales and Marketing
- Operations / Production
From the following Industries:
- Medical Devices, Pharmaceuticals, Dietary Supplements, Biologics, Human Tissue, Combination Products
Suggested formats / content will be shown in the PPT slides.