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Pharmaceutical Quality

This 2-day training course is designed for Pharmaceutical Quality professionals. Delegates will examine Root Cause Analysis(RCA) techniques by applying them to practical examples from the industry.<br>For more info visit - https://aureliusglobalmasterclass.com/events/pharmaceutical-quality-qrm-capa-rca/

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Pharmaceutical Quality

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  1. Pharmaceutical Quality: QRM, CAPA & RCA

  2. About Masterclass This 2-day training course is designed for Pharmaceutical Quality professionals. Delegates will examine Root Cause Analysis(RCA) techniques by applying them to practical examples from the industry. 2

  3. OVERVIEW OF PHARMACEUTICALS QUALITY MASTERCLASS ▪ Event Date 05- 06 December 2019, ▪ Location – Austria 3

  4. 1. KEY TOPICS PHARMACE UTICALS QUALITY Let’s start with the first set of slides 4

  5. “ • Application of Quality Risk Management (QRM) • Regulatory Requirements for RCA, CAPA and OOS • Causal Analysis: Definition of different types of cause • RCA techniques, concepts and stages • Data acquisition and Task analysis • Principles of Critical Deviation Management (CDM) • CAPA Audit expectations • Training/retraining and Human Error 5

  6. OUR CONCEPT How to translate theoretical scale up models and current regulatory guidances into practice – What is really relevant? 6

  7. PHARMACEUTICALS QUALITY A complex idea can be conveyed with just a single still image, namely making it possible to absorb large amounts of data quickly. 7

  8. Thank you very much for your time If you have any questions about this document please don’t hesitate to contact us at: Website: aureliusglobalmasterclass.com Email: masterclass.registrations@aurelius.in 8

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