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DTSTART:20230101T000000
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DTSTART;VALUE=DATE:20230906
DTEND;VALUE=DATE:20230908
DTSTAMP:20260701T072341
CREATED:20230809T155349Z
LAST-MODIFIED:20230809T155349Z
UID:2630-1693958400-1694131199@52.56.119.59
SUMMARY:Quality Risk Management An ICH Q9 Training Course
DESCRIPTION:Join Novatek Europe at ECA Quality Risk Management An ICH Q9 Training Course \n\nSpeakers\n  \nAlexandra Bauloye\, GSK Belgium\nChristof Langer\, OSConsulting\, Austria\nAidan Madden\, FivePharma\, Ireland\nDr Franz Schönfeld\, GMP Inspector\, Germany\n  \n\n\nObjectives\n  \nThis ECA training course deals with the practical implementation of Quality Risk Management (QRM). You will learn how to implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators.\n  \n\n\nBackground\n  \nThe ultimate responsibility for the performance of a medicinal product over its lifetime\, its safety\, quality and efficacy\, lies with the marketing authorisation holder (MAH). To achieve the quality objective\, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice\, Quality Control and Quality Risk Management.” [EU-GMP Guidelines\, Part 1\, Chapter 1]. \nQRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline\, which has been incorporated in the EU-GMP Guidelines\, Part 3. In the course of implementing ICH Q9\, risk-based approaches increasingly gained in importance. Before that\, it was often the case that processes were defined\, implemented and documented to the latest detail. Now\, based on risk assessments\, more flexibility is possible\, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.\n  \n\n\nTarget Group\n  \nThis training course is designed for members of staff in pharmaceutical\, biopharmaceutical and API industry’s production and quality units\, who establish\, manage and use quality risk management systems.\n  \n\n\n\nProgramme\n  \nICH Q 9 – Quality Risk Management: an Overview\n\nQRM in non-GxP industries\nQRM in pharma\nHistorical GMP Situation\nICH Q9: current Revision\nQRM tools and techniques\n\nThe Inspector’s View\n\nExpectations\nIntegration in the Pharmaceutical Quality System\nExamples for good and not so good practice\n\nHow to realise Quality Risk Management in a GMP Environment\n\nThe term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice on how implement QRM:\n– Chapter 1\n– Chapter 2\n– Annex 1\n– Annex 15\n– Annex 16\nSOPs needed\nAuditing\n\nInteractive Session: Applying Principles of QMR after an Incident has happened\nA problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.\n\nDesign of an Event Handling System based on a Quality System and Quality Risk Management Approach\n\nQRM in the Quality System\nDesign of an Event Handling system based on QRM and Management Review\nUse of QRM in the evaluation of Events\nExamples\n\nCase Study: Quality Risk Register\n\nWhat is it\, how to develop it and which type of risks to include\nWhat to show to authorities?\nThe way to business continuity\nExamples\n\nHow to implement Quality Risk Management in a pharmaceutical Company\n\nPart 1: QRM Tools made practicable in daily life\n– ICH Q9 and other Norms (with takeaways for Pharma)\n– Strength of practical DMAIC methodology\n– QRM culture: principles and examples\n– Cost of Quality/Compliance\nPart 2: Examples\n– Change Control\n– Monitoring\n– Maintenance
URL:http://52.56.119.59/event/quality-risk-management-an-ich-q9-training-course/
LOCATION:Barcelo Sants Hotel\, Pl. Països Catalans\, Barcelona\, Catalunya\, Spain
CATEGORIES:Conference
ORGANIZER;CN="ECA Foundation":MAILTO:info@eca-foundation.eu
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