Managing GMP Deviations Using Quality Risk Management …

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22/03/16 Managing GMP Deviations Using Quality Risk Management (QRM). CBE Pty Ltd This training program is copyright to CBE Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded in any form without its express written permission. CBE DCVMN 110 V4 Introduc0on 1. Three Day Program Monday - Presentations Management of Deviations /Investigations and CAPA. Change Management Video and Group Discussion (Trevor). Tuesday Morning - Presentations Sterile Manufacturing GMPs What Regulators and Inspectors Look For Data Integrity Tuesday Afternoon Workshops Deviations , QRM and CAPA.

• Failure Mode, Effects, and Criticality Analysis (FMECA) • Fault Tree Analysis (FTA) • Hazard Analysis and Critical Control Points (HACCP) • Hazard Operability Analysis (HAZOP) • Supporting statistical tools The formality of quality risk management should reflect the complexity and/or criticality of the issue to be addressed.

  Analysis, Failure, Effect, Criticality, And criticality analysis, Fmeca