Computer System Validation 2018 Fundamentals

Overview:
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

Why should you Attend:
Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.

Areas Covered in the Session:
Validation strategy
Requirements documentation
Complexity and risk analysis
Creating a detailed test plan based on risk
Supplier qualification
IQ, OQ and PQ

Who Will Benefit:
Computer System Developers
Systems Development Engineers
QA/ QC
Lab Managers and Analysts
Production Managers
Engineering Managers

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]