Defining Computer System Validation & Software Development Life-Cycle 2013

Topics

• 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

Who should Attend

• 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