Program Overview
This training program is designed to equip pharmaceutical professionals with the knowledge and tools to effectively identify, assess, mitigate, and monitor risks in their operations. Covering both foundational principles and advanced applications, the program emphasizes real-world scenarios, regulatory requirements (ICH Q9, WHO, EU GMP), and industry best practices. Through interactive sessions, case studies, and hands-on activities, participants will learn to integrate QRM into core processes like manufacturing, QC testing, and regulatory inspections, ensuring proactive risk management and continuous operational improvement.
Features
- Understand and apply QRM principles as per global regulatory standards (ICH Q9, WHO, EU GMP).
- Use tools like FMEA, HACCP, and Risk Ranking to identify, analyze, and control risks.
- Integrate QRM practices into manufacturing, QC, and regulatory compliance processes.
- Develop and implement effective risk mitigation strategies to enhance operational quality.
Target audiences
- Professionals from pharmaceutical operations and quality departments.
Curriculum
- 8 Sections
- 29 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Introduction to Quality Risk Management4
- QRM Process Overview3
- 2.1Steps of the QRM process: Risk Identification, Risk Analysis, Risk Evaluation, Risk Control, and Risk Review.Steps of the QRM process: Risk Identification, Risk Analysis, Risk Evaluation, Risk Control, and Risk Review.
- 2.2Tools and techniques: FMEA (Failure Mode and Effects Analysis), Fishbone Diagram, HACCP, and Risk Ranking.
- 2.3Case study on selecting the right tool for a specific pharmaceutical scenario.
- Risk Assessment in Pharma Operations3
- Risk Control and Mitigation Strategies4
- Risk Management in Key Pharma Areas4
- 5.1Application of QRM in manufacturing: Validation, equipment qualification, and process changes.
- 5.2QRM in product lifecycle management: R&D to commercial production.
- 5.3Risk assessment in QC: Stability studies, OOS (Out of Specification), and laboratory deviations.
- 5.4Activity: Team-based analysis of real-world risk scenarios (e.g., contamination event or supply chain disruption).
- QRM in Regulatory Inspections4
- Continuous Risk Review and Monitoring4
- Case Studies and Best Practices3
Instructor
