Netzealous LLC DBA - Compliance4All, Online
2018-10-23
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
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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