Quality Events
High-level overview of quality event management principles and practices.
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.
Course Modules/Learning Objectives
- Events in General
- Deviation Management
- Investigations
- Complaints
- Out of Specifications (OOS)
- Product Recall Management
- Environmental Monitoring Excursions
- CAPA
Registration Fee
| Member | Nonmember |
|---|---|
| US$270 | US$300 |