Good Documentation Practices to Support FDA Computer System Validation 2019

Topics

• "GxP" - Good Manufacturing, Laboratory and Clinical Practices
• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Data Archival to ensure security, integrity and compliance
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Learn the requirements for documenting efforts related to systems governed by FDA
• Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
• Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
• Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

Who should Attend

• Information Technology Developers and Testers
• Information Technology Analysts
• Analytical Chemists
• QC/QA Managers and Analysts
• Automation Analysts
• Laboratory Managers
• GMP Training Specialists
• Computer System Validation Specialists
• Business System/Application Testers
• Business Stakeholders/Subject Matter Experts
• Quality Managers, Chemists and Microbiologists
• Clinical Data Managers and Scientists
• Consultants in the Life Sciences and Tobacco Industries
• Regulatory Affairs Personnel
• Interns Working at the Companies Listed Above