The Use of Quality Risk Management to Support Commissioning & Qualification - System Risk Assessment
Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EST
Session Length: 1 hour
System Risk Assessments (SRAs) play a pivotal role in the application of science- and risk-based approaches to commissioning and qualification (C&Q) activities. As emphasized in ISPE’s Commissioning and Qualification Baseline Guide Volume 5, Volume 2 – Commissioning & Qualification, SRAs are essential for determining the appropriate level of rigor and documentation for systems and equipment throughout the lifecycle of pharmaceutical facilities.
This webinar will provide a comprehensive overview of the SRA process as outlined in the ISPE Baseline Guide. We will explore how SRAs support critical decision-making by identifying system critical quality attributes and system critical process parameter that impact product quality and patient safety, determining direct versus no impact systems, and applying Good Engineering Practice (GEP), commissioning, or qualification strategies accordingly.
Attendees will gain a practical understanding of how to conduct and document SRAs, supported by real-world examples that demonstrate best practices and common pitfalls. Emphasis will be placed on the integration of SRA into project workflows, the alignment with Quality Risk Management (QRM) principles from ICH Q9, and the value of cross-functional collaboration in achieving compliant and efficient outcomes.
Whether you are new to risk-based C&Q or looking to refine your approach, this session will offer actionable insights to enhance the effectiveness of your SRA efforts and ensure alignment with industry expectations.
Learning Objectives
- Understand the Role of SRAs in C&Q
Learn how System Risk Assessments fit into the overall commissioning and qualification process, and how they support a science- and risk-based approach aligned with ISPE Baseline Guide Vol. 5, Vol. 2 - Apply Practical SRA Methodology
Gain actionable knowledge on how to perform and document SRAs effectively, including how to distinguish between direct and indirect systems and determine the appropriate strategy—GEP, commissioning, or qualification. - Leverage Real-World Examples for Better Implementation
See how SRAs are used in real projects, recognize common challenges, and discover best practices that enhance compliance, efficiency, and cross-functional collaboration.
