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Abstract
Students learn about pharmaceutical regulations in Switzerland, EU and US, various quality systems and CAPA, quality risk management, life cycle management, quality assurance of biotechnological processis, process validation, quality by design, statistical tools in QA, computerized systems validation, quality aspects of packaging and the role of the qualified person.
Objective
• Quality Risk Management • Quality Systems and CAPA • Pharmaceutical Regulations, Swissmedic and ICH Basics • GMP and its Legal Basis • US Regulations and Enforcement Systems • GxP Requirements with Focus on Distribution • Change Mangement, Life Cycle Mangement • Case Studies for Analytics and Production • QA of Biotechnological Processes • Quality Aspects of Therapeutic Antibodies • Workshop: How to write an effective SOP • Process Validation with Examples • Quality by Design • Statistical Tools in QA • Challenges and Trends in QA • Computerized Systems Validation • Quality Aspects of Packaging
Resources
Lecture Notes
Course documents as a link to the electronic version, are distributed upon payment about one week ahead of the module start.