Risk Based Computer System Validation


Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 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. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical En........

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 the validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.
How to plan and conduct a risk-based validation will be explained. The overall risk for a 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. 

Why should you attend this webinar?

Validation of computer system software is completely different than the 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.
You will learn in detail:
  • How to manage the validation process
  • Validation life cycle models and Validation Plan contents
  • How to determine the complexity category of your system based on GAMP 5 principles
  • How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure
  • What level of testing is necessary based on software complexity and risk
  • Integrating software supplier evaluation into the validation process
  • What documentation is necessary
  • how to minimize documentation to reduce costs based on risk
  • How to plan and conduct IQ, OQ, and PQ 

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCEW0018

Training Options:

Duration: 60 mins

 04/01/2019

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

Refund Policy
Upcoming Webinar of Edwin Waldbusser
Risk Based Computer System Val....
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When: 04/01/2019 | 10:00 AM PT |01:00 PM ET
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