Continued Process Verification (CPV): Using Review-by-Exception Approaches for Process Monitoring and Product Quality

Continued Process Verification (CPV) programs often generate large volumes of process data, trend reports, investigations, and periodic reviews. As outlined within FDA's Process Validation Guidance and supported by ICH Q10 lifecycle principles, organizations are expected to maintain an ongoing state of control throughout commercial manufacturing. While companies collect extensive information to demonstrate process performance, many teams continue to struggle with a practical challenge: identifying which signals genuinely require attention and which represent expected process variability. As manufacturing systems become increasingly digital and data-rich, traditional approaches that attempt to review everything with equal intensity can create inefficiencies while potentially obscuring the issues that matter most.

This session examines how review-by-exception approaches can be applied within CPV programs to improve process monitoring, focus resources on meaningful signals, and support product quality decisions. The discussion will explore how organizations establish review thresholds, interpret process trends, evaluate emerging risks, and determine when intervention is warranted. Practical examples will be used to illustrate how exception-based review strategies can strengthen oversight while maintaining confidence in process performance and product quality.

| WHY YOU SHOULD ATTEND

CPV programs rarely fail because information is unavailable. In many organizations, the opposite is true. Teams are surrounded by process data, trend reports, statistical outputs, investigations, and periodic reviews. The difficulty lies in knowing when available information justifies intervention and when observed variation remains consistent with an acceptable state of control. Acting too early can create unnecessary investigations and resource burden. Acting too late can allow process drift and quality risks to develop unnoticed.

Stage 3 Continued Process Verification was never intended to become a data collection exercise. FDA and ICH Q10 expectations place emphasis on using process knowledge to support informed decisions throughout the commercial lifecycle. Review-by-exception approaches require organizations to determine which signals deserve attention, what constitutes meaningful change, and how much evidence is needed before action is taken. This session focuses on the judgment required to make those decisions consistently and defensibly.

| AREAS COVERED

• Stage 3 Continued Process Verification Expectations Under FDA Process Validation Guidance
• Review-by-Exception Approaches for Modern CPV Programs
• Process Signals That Deserve Investigation, Escalation, or Action
• Process Drift, State of Control, and Emerging Product Quality Risks
• Exception Criteria That Support Effective Ongoing Process Monitoring
• Process Performance Trends and Their Impact on Quality Decisions
• Evidence Supporting Corrective Actions Within CPV Programs
• ICH Q10 and Regulatory Expectations for Ongoing Process Verification

| WHO SHOULD ATTEND

• Quality Assurance (QA)
• Process Validation Professionals
• Manufacturing and Operations Personnel
• Quality Control (QC)
• Process Engineers
• Manufacturing Science and Technology (MS&T)
• Compliance and Quality Systems Professionals
• Regulatory Affairs and Technical Management Teams

Course Director: Meredith Crabtree

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.