Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
Areas Covered in the Session :
- Learn the requirements for documenting efforts related to systems governed by FDA
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures.
- Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
- Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
- Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance
- Interactive Q&A Session
Who Will Benefit:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.