Overview

Description :
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.

How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. You’ll learn how to integrate risk based supplier evaluation into the validation process.

Validation Master plan and System Validation Plans will be explained

Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.

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

About Speaker:
Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

Edwin Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.



Venue: Online / Webinar
Location: Online
Country: United States

Organiser Contact Details:
Sam Miller
T: 1-844-216-5230
support@compliancetrainingpanel.com