Applying Quality Risk Management (QRM) (T42)

Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Primer Webinar

Description

Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9, however, the application and the complexity of the tools needs to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny. The criteria for risk ratings and mitigation requirements should be clearly defined in advance of commencing the risk assessment. With the necessity to track and monitor the outputs of risk assessments and use them for the purposes of trending and the development of the site risk management file and risk dashboard, risk communication is key in the overall QRM process.

QRM principles require that the evaluation of risk to quality is based on scientific knowledge and the protection of the patient. In so doing the level of effort, formality and documentation of the QRM process is commensurate with the level of risk and the overall approach should be defined in a formal Risk Management Plan (RMP) for the site. To date the application of ICHQ9 is evident in risk based approaches to C&Q but to a lesser extent holistically throughout the product lifecycle.

Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle, including but not limited to:

• All processes, tests, systems, equipment and facilities related to the clinical and commercial manufacturing of products
• New product and process development and transfer
• Change control
• Vendor selection and qualification
• Supplier management
• Corrective and preventative actions
• Complaint handling
• Deviations
• Inspections both internal and external
• Training
• New regulatory requirement
• Trends from quality indicators, periodic quality and product reviews
• New business strategies that may have a critical impact on the quality system
• Stability monitoring
• Validation approach

NOTE: It is strongly recommended that participants should be familiar with basic concepts of ICHQ8 R2, ICH Q9 and ICH Q10 and a fundamental understanding of risk-based C&Q prior to attending this course. The course will not focus on the detail of the tools but the overall Risk management process. However worked examples of different tools will be given to enhance learning and understanding.

Webinar 

We recommend participants complete the primer course webinar that provides the background for the origins of the ICH guidelines, Q8 (R2), Q9, Q10 and the basic concepts of risk-based C&Q to provide a foundation to the QRM process.

This course includes the primer webinar. Access information will be provided via email one week prior to the start of the training event.

Course Modules

Day 1

• Regulatory background for QRM
• The QRM process and roadmap – process understanding, C&Q, adverse events to routine manufacturing
  • Breakout 1 – What should the scope of QRM be?
  • Breakout 2 – Process Risk Assessment
• QRM tools formal versus informal
  • Breakout – What tool is suitable and when?
• Risk Management Plan Development and implementation
  • Breakout – Development of a Risk Management Plan outline.

Day 2

• Review of Day 1
• Risk decision tree/matrix
  • Breakout – Application of a risk decision tree
• Risk ranking and trending - overview of the process
• Risk dashboards
  • Breakout- development and maintenance
• How to apply the QRM principles in your own organisation, roles and responsibilities and training?
  • Breakout - brainstorming – Where are we now and where do we need to get to holistically to implement QRM?
• Roadmap to QRM implementation

Take Back to Your Job

• Understand the philosophy and application of a holistic lifecycle-based QRM process through the development of a Quality Risk Management Plan
• Learn how to develop and implement a risk decision tree and the appropriate use of risk assessment tools
• Develop the ability to apply risk management methodologies throughout design and verification phases
• Understand the Risk Based Approach for the Delivery of Facilities, Systems, Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
• Understand how these documents align with the overall implementation of a robust QRM system that is applicable for the product lifecycle
• Explain the link between risk assessments, design review, and lifecycle based quality risk management
• Understand the expected format of the risk management plan and file inclusive of risk ranking
• Summarize US / EU / SFDA / and WHO regulatory requirements, citations and expectations that may influence the implementation of a holistic QRM process

Attendance Suggested For

• Intermediate and management level Quality and Compliance Managers.
• Intermediate practitioners of Commissioning and Qualification who want to understand and use QRM.
• Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the Commissioning and Qualification ISPE Communities of Practice.

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Commissioning and Qualification. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.