Desription
Risk Management is a core requirement across all pharmaceutical, biotech, food, and chemical operations.
This Risk Management Workshop provides a complete, practical understanding of how to identify, evaluate, mitigate, and monitor risks using globally recognized frameworks such as ICH Q9 (Quality Risk Management), ICH Q10, FDA & EMA guidelines, Annex 1 (2022), and PIC/S expectations.
Participants learn how risk thinking is integrated into quality systems, manufacturing processes, laboratory operations, validation activities, contamination control, engineering systems, supply chain, and decision making.
Through real case studies and hands-on exercises, the workshop develops the ability to choose the right tools, build cross-functional risk assessments, and design effective mitigation strategies.
By the end of this workshop, participants will be able to:
- Apply ICH Q9 risk management concepts to real GMP operations
- Build structured risk assessments for processes, equipment, labs & sterile areas
- Identify hazards and establish scientifically justified acceptance criteria
- Use FMEA, FTA, HACCP, and qualitative/quantitative risk tools effectively
- Integrate risk-based thinking into audits, investigations, CAPA, validation & CCS
- Evaluate and manage risks related to people, materials, equipment & methods
- Implement lifecycle monitoring and continual improvement
- Strengthen inspection readiness through documented, transparent risk analysis
Who Should Attend
This workshop is ideal for professionals across all regulated sectors, including:
- Quality Assurance & Quality Control Staff
- Production & Manufacturing Teams
- Validation, Qualification & Engineering Personnel
- Microbiology, Sterility Assurance & Laboratory Teams
- Regulatory Affairs & Compliance Specialists
- Supply Chain & Warehouse Quality Teams
- Anyone involved in decision-making, troubleshooting, or CAPA investigations
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform.
Course Topics
- Risk Management approach and Tools ICHQ9
- Cross Contamination Prevention Risk Assessment
- Material Handling Risk Assessment
- Utilities risk assessment.
- Environmental monitoring ( EM) risk assessment
Number Of Sessions
5 Sessions