Manufacturing, testing and distribution of active pharmaceutical ingredients and medicinal products must be planned and executed as risk-based approach. Requirements ae outlined on international level in ICH Q9 guideline on Risk Management. Authorities worldwide follow these guidelines which are an integral part of Part III of the EU GMP. The ISPE Baseline Commissioning and Qualification also emphasizes the risk-based classification of equipment and facilities.
The live online ICH Q9 course "Risk Analyses in Practice" from Concept Heidelberg on April 07, 2022 will focus on GMP-compliant application examples from API manufacturing, pharmaceutical development, qualification and validation, and pharmaceuticals manufacturing. Peter Bappert, Managing Director of gempex GmbH, and Dr. Martin Melzer, Principal Consultant at gempex, will step in as GMP experts and enrich the proven group of speakers with their GMP expertise.
The seminar addresses specialists and executives from mechanical and plant engineering, and from the areas of development, production, quality control and quality assurance in the pharmaceutical industry, who would like to learn or refresh their knowledge of risk management and the practical implementation of risk analyses.
Learning contents of the event are:
- Case study introduction of a risk management system
- Failure mode and effects analysis (FMEA)
- From GMP risk identification to qualification strategy - practical example from API production
- Assessment matrices for analyzing the manufacturing process of an aseptically produced freeze-dried product - benefits from the perspective of pharmaceutical development
- HACCP
- Example: Risk analysis for cross-contamination (EU GMP Guideline Part I, Chapter 5.21)
For further questions regarding risk management and risk analyses, please contact gempex Peter Bappert and Dr. Martin Melzer: info@gempex.com
The complete program of the ICH Q9 course "Risk Analyses in Practice" and more information about all speakers can be found here.