'Software validation' diaporamas de présentation

Module 9: Validation - OQ

Module 9: Validation - OQ. Module 9 Purpose and Objectives. Module Purpose: Process optimization requires understanding the process. The student will review the detail for a Validation. Module Objectives: After this module, you will be able to

551 views • 38 slides

Surviving an FDA Audit

Surviving an FDA Audit. Richard Chapman, FDA TwinSPIN University of Minnesota January 14, 2010. Who am I?. Richard C. Chapman Software Engineer Food and Drug Administration Center For Devices and Radiological Health Office of Science and Engineering Laboratories

705 views • 38 slides

Chapter 2.11

Chapter 2.11. Program Validation. = Reliable Hardware AND Reliable Software AND Compatible Hardware and Software. Reliable System. Good Design Diagnostic Circuits Build-in Redundancy Diagnostic Programs. Reliable Hardware. should be ADEQUATE (accomplishes the tasks it is used for)

365 views • 35 slides

MethodGXP

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Audit of IT Systems SARQA / DKG Scandinavian Conference, October 2002, Copenhagen

Sue Gregory. Audit of IT Systems SARQA / DKG Scandinavian Conference, October 2002, Copenhagen. Purpose of IT System Audit. To assure that established standards are met for all phases of the validation, operation and maintenance of computerised systems.

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LDMS Validation and Audit Readiness

457 views • 23 slides

Automating Fermentation

Automating Fermentation. Presenters. Todd Ham Automation Engineer Emerson Process Management, Life Sciences, Food, and Beverage Todd Edgington Automation Engineer Genentech NIMO Facility, Oceanside, CA. The NIMO Project Overview.

700 views • 21 slides

Automating Fermentation

Automating Fermentation. Presenters. Todd Ham Automation Engineer Emerson Process Management, Life Sciences, Food, and Beverage Todd Edgington Automation Engineer Genentech NIMO Facility, Oceanside, CA. The NIMO Project Overview.

419 views • 21 slides

The CDRH Software Message (October 19, 2002)

The CDRH Software Message (October 19, 2002). John F Murray Jr.. Center for Devices & Radiological Health US Food and Drug Administration JFM@CDRH.FDA.GOV. Mr. John F Murray Jr. Mr. Murray currently serves as the: Software and Part 11 Compliance Expert Office of Compliance

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LHCb Computing Tasks

LHCb Computing Tasks. December Status of Computing Personnel. Currently available people insufficient to cover all activities Estimate ~40 FTE needed 22.6 FTE available for operations Some activities not covered

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Validation Workshop

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Validation Workshop

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Air Transport Recorders Crash Survivability

Air Transport Recorders Crash Survivability Duncan Schofield Manager, Flight Recorder Engineering Topics What are Flight Recorders Why do commercial aircraft carry them How performance is specified TSO Specification evolution TSO Survival Requirements

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Better Insights For ISO 13485 2016 Validation Requirements

It is always better to look for a detailed approach mentioning various consequences and rules and regulations related to the same. This may youu2019d come up with a better handle for the ISO 13485 2016 update. Contact details u2013 Phone no - 9325283428 Mail - dm@operonstrategist.com Visit us - https://www.operonstrategist.com/better-insights-for-iso-134852016-validation-requirements/#utm_source=classified submission&utm_medium=classified page&utm_campaign=classified submission

70 views • 6 slides

Better Insights For ISO 13485 2016 Validation Requirements

It is always better to look for a detailed approach mentioning various consequences and rules and regulations related to the same. This may youu2019d come up with a better handle for the ISO 13485 2016 update. Contact details u2013 Phone no - 9325283428 Mail - dm@operonstrategist.com Visit us - https://www.operonstrategist.com/better-insights-for-iso-134852016-validation-requirements/#utm_source=classified submission&utm_medium=classified page&utm_campaign=classified submission

64 views • 6 slides