制药工业前沿 统计学在验证中的应用 Use Statistics in Validation.pdfVIP

Introduction to Statistics in Validation PRACTICAL APPROACH FOR VALIDATION AND QUALITY ENGINEERING PROFESSIONALS Raul Soto, MSc, CQE IVT Conference - March 2017 Amsterdam, Netherlands (c) 2017 Raul Soto 1 The contents of this presentation represent the opinion of the speaker; and not necessarily that of his present or past employers. (C) 2017 RAUL SOTO 2 About the Author • 20+ years of experience in the medical devices, pharmaceutical, biotechnology, and consumer electronics industries – MS Biotechnology, emphasis in Biomedical Engineering – BS Mechanical Engineering – ASQ Certified Quality Engineer (CQE) • I have led validation / qualification efforts in multiple scenarios: – High-speed, high-volume automated manufacturing and packaging equipment; machine vision systems – Laboratory information systems and instruments – Enterprise resource planning applications (i.e. SAP) – IT network infrastructure, Cognos Business Objects reports – Manufacturing Execution Systems (MES) – Mobile apps – Product improvements, material changes, vendor changes • Contact information: – Raul Soto rsoto21@ (c) 2017 Raul Soto 3 What this talk is about • Introduce and describe some of the main stat