Good Documentation Practices for FDA-Regulated Computer Systems 2017

Topics

• 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

Who should Attend

• 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