Workshop Overview

Analytical method validation has long been treated as a milestone — something you complete, file away, and revisit only when a problem arises. That model is changing. The United States Pharmacopeia has proposed a landmark new General Chapter, Ongoing Procedure Performance Verification (OPPV), that formally establishes requirements for demonstrating — on a continuous, risk-based basis — that analytical procedures remain fit for purpose throughout their entire working life.

As Stage 3 of the Analytical Procedure Lifecycle framework introduced in USP , this new chapter fills a critical gap that regulators and industry have long recognized: the absence of compendial guidance on what happens to method performance after validation. For the first time, pharmaceutical laboratories will have a structured, ICH-aligned framework for proactive monitoring, trend detection, and continuous improvement of their analytical procedures.

This webinar, led by the expert consultants at AAPS Pharma, provides a clear, practical introduction to USP . Participants will leave with a clear understanding of what OPPV requires, how it differs from existing system suitability tests, what statistical tools it introduces, and what practical steps organizations can take today — whether their procedures have a formal Analytical Target Profile or not.

With the public comment period closed and finalization on the horizon, there has never been a better time to get ahead of this standard.

Who Should Attend

This webinar is designed for professionals working in GMP-regulated pharmaceutical, biotechnology, and contract laboratory environments, including:

• QC Analysts and Senior Analysts
• QC Managers and Laboratory Directors
• Quality Assurance and Compliance Professionals
• Analytical Development and Method Validation Scientists
• Regulatory Affairs Specialists (CMC focus)
• Method Transfer Leads
• GMP Auditors

No prior familiarity with USP or the Analytical Procedure Lifecycle framework is required. Participants with a working knowledge of method validation and GMP laboratory operations will get the most from this session.

Workshop Outline

Part 1 — Introduction

• What is USP ?
• What new concepts does it introduce?
• Relationship with current guidelines
• Status and timeline

Part 2 — Rationale and Interpretation: Where Are We Now?

• ATP justified during method development — rarely revisited post-launch
• Typical current QC lab approach to OPPV
• FDA inspection trends relating to analytical laboratory controls

Part 3 — Rationale and Interpretation: Where Are We Going?

• What USP is trying to improve
• Identifying the current gaps in pharmaceutical QC laboratories

Part 4 — Rationale and Interpretation: How Do We Get There?

• What data is required for assessment, and how do we assess it?
• Keep it simple — the control chart approach
• How to capture the data — practical infrastructure options
• Where labs may face implementation and inspection challenges
• Practical example — HPLC-UV assay for API release

Part 5 — Final Thoughts

• What can be done now?
• What are we waiting for?
• SOP finalization strategy
• Thresholds and acceptance criteria — what can be set now vs. what waits
• Tool selection tied to final text

Learning Outcomes

• Upon completing this webinar, participants will be able to:
• Explain the purpose of USP and its role as Stage 3 of the Analytical Procedure Lifecycle
• Describe how Ongoing Procedure Performance Verification (OPPV) differs from System Suitability Testing
• Identify the key elements of a risk-based performance monitoring plan under
• Apply OPPV principles to both ATP-linked procedures and legacy procedures without a defined ATP
• Interpret and apply the statistical tools introduced in the chapter, including control charts and trending rules
• Understand how interconnects with USP , , and
• Assess their organization’s current readiness gaps relative to the proposed standard
• Identify immediate next steps for OPPV implementation in a GMP laboratory environment

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop. Workshop registration is intended for individual use only. Each registration grants access to one participant. If you plan to attend as a group or company team, please ensure that each participant is registered separately. Group rates and corporate packages are available—contact us for details.

Refunds are only available if cancellation is requested at least 48 hours before the workshop. No refunds will be issued for late cancellations.