Transcription of Managing GMP Deviations Using Quality Risk Management …
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Managing GMP Deviations Using Quality Risk Management …
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. Thursday Workshops Stream 1 Change Management and QRM. Stream 2 - Sterile Manufacturing Assessing OOS/OOT for Microbiological Events CBE DCVMN 110 V4 2. 1 22/03/16 Module Topics Quality Risk Management Devia3ons and Quality Events Inves3ga3ons CAPA and Con3nuous Improvement CBE DCVMN 110 V4 Introduc3on Quality Risk Management Basic Principles Refresher QRM is well established in all cGMPs since 2004.
• Review of risk management experience Risk Identification Risk Acceptability Decisions Risk Evaluation Risk Assessment Risk Control • Option analysis • Implementation • Residual risk evaluation • Overall risk acceptance! Risk Control Risk Analysis 6
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