Conference Description:

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.

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 Should Attend:
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.Examples of who will benefit from this webinar include:

>. 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