DESCRIPTION This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are: How does testing fit into GaMP5 lifecycle Risk based methodology for testing How do I leverage supplier testing What should I test? How much testing is enough? How should I conduct the tests How should I document my testing How do I maintain the testing integrity of my system Testing related 483s and Warning Letters Case Studies

Date : 20th November 2017 to 21st November 2017

Place : Australia, Sydney

Website :https://www.eventbrite.com/e/a-risk-based-approach-to-testing-of-computerized-gxp-systems-com-a-tickets-38830478005?aff=NDT

Contact Person:Paula Edwards

Description:

DESCRIPTION This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are: How does testing fit into GaMP5 lifecycle Risk based methodology for testing How do I leverage supplier testing What should I test? How much testing is enough? How should I conduct the tests How should I document my testing How do I maintain the testing integrity of my system Testing related 483s and Warning Letters Case Studies

DESCRIPTION This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are: How does testing fit into GaMP5 lifecycle Risk based methodology for testing How do I leverage supplier testing What should I test? How much testing is enough? How should I conduct the tests How should I document my testing How do I maintain the testing integrity of my system Testing related 483s and Warning Letters Case Studies will be held in Sydney,Australia on date 2017-11-21

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Deadline for abstracts/proposals : 19th November 2017

Keynote Speakers : Angela Bazigos Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as w

Conference Highlights :Topic Background: Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. “Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits an

Venue :Sydney, NSW, 2000, Australia

Check the event website for more details.