Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks.

The application and the complexity of risk management tools need to be appropriate to the scope of the risk event, the level of risk, the desired output from the risk assessment.

Successful completion of this one day course provides learners with understanding of the principles of Quality Risk Management (QRM) and its practical application as per ICHQ9. This is an interactive workshop to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain.

While some case studies will be provided, participants are invited to bring examples (made generic or non-specific if necessary) where they have found application of risk tools challenging for the group discussion and engagement or to work on their own scenarios. Case studies may come from any area of the business where QRM is applied e.g.

• New product and process development and technology transfer
• Quality Management System elements:
  • Audit management
  • Deviations
  • Complaint investigations
• Vendor selection
• Production

Objective

At the end of the course learners will:

• Be aware of the regulatory drivers for QRM
• Know when to initiate and plan a quality risk management process
• Interpret the principles of QRM as defined in ICH Q9
• Be able to set up and run a risk management exercise, including team selection, risk assessment, analysis, control, review and communication
• Appreciate how to use a few of the common tools e.g. FMEA, risk ranking, cause and effect matrix, process flow diagrams, fishbone, brainstorming
• Appreciate the importance of QRM documentation and Risk Registers

Outline

• Introduction and Scope of ICHQ9 Quality Risk Management
• Principles of Quality Risk Management
• Roles and Responsibilities
• General Quality Risk Management Process
  • Risk initiation
  • Risk Assessment
  • Risk Control
  • Risk Review
  • Risk Communication
• Integration of QRM process into Industry and Regulatory operations
• Some applications for QRM, including exercises and design of system
• QRM documentation and Risk Register

Who should attend

The course is suitable for people in development, manufacturing, engineering or validation who may have no, or limited quality risk management experience or for those with experience but who wish to be updated with the latest application, particularly regarding science and risk based principles.

Methodology

• Presentation
• Discussions
• Exercises

Agnes Lim's Profile

Armed with a BSC (Hons) from the National University of Singapore, a MBA from the University of Hull and an Advanced Certificate for Training and Assessment (ACTA) by Institute of Adult learning (IAL), Agnes Lim has more than 30 years of corporate experience in the biomedical industry of which 20 years were in middle and senior management.

Adept at people management, she has more than 20 years experience in hiring, managing, training and developing staff and more than 10 years experience in succession planning at the site leadership level. She is able to connect with people across different levels in the organisation having worked up the levels in her career. She has conducted more than 300 interviews ranging from junior management staff to site leadership team members to scholarship aspirants at her previous companies.

Being in a technical department, Agnes is equally well versed in technical report writing and technical presentation, having created and reviewed many thousands of technical reports and presentations throughout her career.

Agnes has developed and conducted numerous trainings and coached learners on both technical and soft skills. Examples of trainings that she has conducted include, How Managers and supervisors can Develop Career of their Staff, Hire Right, Managing your Career Development for Success, Technical Writing Skills, Technical Presentation skills, Auditing Skills, Investigations Skills, Data Integrity, Quality Risk Assessments amongst others.

A comfortable and confident speaker, she was invited to speak at BioBiz at NUS previously to help the students have a better understanding of the career opportunities in the biomedical / pharmaceutical industry. She has also shared her educational choices with students at Raffles Girls School (Secondary), her alma mater.

Agnes is passionate about developing and cultivating talents within the organisation. She believes that a keen focus on talent development differentiates organisations and is a competitive advantage.

With a passion for youth and education, she currently volunteers with ACTS Singapore.