Quality: Events

High-level overview of quality event management principles and practices.

Part 1 of the ISPE Quality Training Series

• Quality: Events
• Quality: Documentation
• Quality: Miscellaneous

This course offers a high-level summary of quality event topics as an addition to the Quality Events SOP Guidance Documents package. Instead of detailing how to carry out each task, it highlights why these elements are vital for a complete quality system. The course covers the core principles of root cause analysis, CAPA implementation, and effective recall and complaint handling, ensuring learners grasp their importance for regulatory compliance and operational excellence. By the end, participants will understand regulatory standards, industry best practices, and practical applications to enhance compliance, uncover process improvement opportunities, maintain product quality, and improve patient safety.

Learning Objectives

By the end of this course, participants will be able to:

• Explain the purpose and regulatory expectations of quality event management systems, including deviations, investigations, complaints, and CAPA.
• Apply structured approaches to root cause analysis and investigation to ensure events are thoroughly assessed and appropriately documented.
• Evaluate the impact of quality events on product quality and patient safety, ensuring timely escalation, classification, and resolution.
• Integrate CAPA processes effectively to address root causes, prevent recurrence, and support continuous improvement within the quality system.
• Strengthen inspection readiness by ensuring quality events are consistently managed, trended, and documented in alignment with regulatory expectations.

Course Modules

This course includes the following modules:

• Events in General
• Deviation Management
• Investigations
• Complaints
• Out of Specifications (OOS)
• Product Recall Management
• Environmental Monitoring Excursions
• CAPA 

Who Should Attend

This course is ideal for:

• Quality Assurance (QA) and Quality Control (QC) professionals
• Manufacturing, operations, and technical staff involved in GMP activities
• Regulatory affairs and compliance professionals
• Personnel responsible for documentation, data governance, and quality systems support
• New or developing professionals seeking foundational knowledge of GMP quality systems

Registration Fee

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses