Good Documentation Practices to Support FDA Computer System Validation 2019 is a webinar that covers topics such as:
- "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
Good Documentation Practices to Support FDA Computer System Validation 2019 is intended for:
- 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
