Good Documentation Practices for FDA-Regulated Computer Systems 2017 is a webinar that covers topics such as:
- The best practices for documenting computer system validation efforts, including requirements, design , development, testing and operational maintenance procedures
- The requirements for documenting efforts related to systems governed by FDA
- How to prepare a procedure that will capture the best practices for FDA compliant documentation
- Examples of incorrect, incomplete or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
- The importance of training as it relates to good documentation practices to ensure FDA compliance
Good Documentation Practices for FDA-Regulated Computer Systems 2017 is intended for:
- QC/QA managers and analysts
- Information technology managers and analysts
- Compliance managers
- Clinical data managers and scientists
- Automation analysts
- Lab managers and staff
- GMP training specialists
- Computer system validation specialists
- Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
