BETCO Consulting

Description: Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risk. It is a mechanism of ensuring process/product quality attributes are maintained throughout the product lifecycle. To ensure the overall quality of product and thereby the safety of the patient, we should consider both proactive (present) and predictive (Future) approaches in the management of our manufacturing process. This can be achieved by implementing an effective Quality Risk Management program. The course provides an introduction to quality risk management. The course covers the key definitions and terminology involved in quality risk management. The course will cover all various step in the QRM as well as it will discuss some important case scenarios.

Learning Outcomes: 

On the completion of this course, participants will: 

• Understand the overall concept of Quality Risk Management ( QRM)
• Understand the regulatory requirement in the area of Quality Risk Management Know key definitions - What is risk, risk management and quality risk management. 
• Know where does risk comes from?
• Understand Failure Mode Effect Analysis (FMEA) methodology in identification, analysis, evaluation and control of risks. 
• Be able to provide a documented, approved rationale for your decisions.
• Understand some case studies on how to apply quality risk management to some operations in the pharmaceutical and biotechnology manufacturing.
  
  

Target Audience: The course is ideal for employees who are working in Risk Management, Product Development, Quality Assurance, Quality Control, Compliance, Projects, Engineering and Maintenance, Validation, Logistics & Warehouses.

Methodology
PowerPoint Presentation & Case studies Exercises

References:

• SFDA GMP Guidelines 2018
• ICH Q9 – Quality Risk Management