Computer System Validation 2018 Fundamentals

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Category Lab Managers and Analysts, Production Managers, Engineering Managers

Deadline: October 22, 2018 | Date: October 23, 2018

Venue/Country: Online, U.S.A

Updated: 2018-08-07 14:27:57 (GMT+9)

Call For Papers - CFP

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

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