Defining Computer System Validation & Software Development Life-Cycle 2013 is a webinar that covers topics such as:
- Development of documentation as required by regulations
- Regulatory requirements of CSV
- FDA’s new 21 CFR Part 11 Guidance, how to use it and why it is important
- Electronic Records and Signatures
- GAMP 5 New Computer System Validation
- FDA’s new risk-based approach
Defining Computer System Validation & Software Development Life-Cycle 2013 brings together:
- Persons subject to Quality System regulation
- Quality Assurance
- Persons responsible for the design, development, production, or procurement of automated tools
- FDA Compliance Officers
- FDA Investigators
- FDA Scientific Reviewers
