Batch Record Review Process What FDA, EU & Health Canada Expect in 2026, Key Elements of the Review Process & Emerging Technologies

Batch record review is one of the most critical and closely inspected processes in pharmaceutical manufacturing, and regulatory expectations from the FDA, Health Canada and the EU have never been more demanding. A poorly designed or inconsistently executed review process is not just an operational burden, it is a direct compliance risk that can lead to investigation findings, Warning Letters and costly production delays. In 2026, regulators are placing heightened emphasis on Good Documentation Practices, risk-based review approaches and management accountability, expecting pharmaceutical companies to demonstrate not only that batch records are reviewed, but that they are reviewed effectively, efficiently and with full traceability. If your current process was not built around these expectations, an inspection will find the gaps before you do.

This live, interactive session with Peter Calcott, Ph.D. gives your team the practical framework to close those gaps. You will learn how to apply tiered, risk-based review strategies that focus rigorous oversight where it matters most while reducing the burden on low-risk elements, how to use Quality Risk Management to prioritize critical aspects of the review, and how to track performance metrics that identify early signs of degraded process health before they become compliance issues. From Good Documentation Practices to the latest technologies reshaping the review process, this session covers everything your QA, regulatory and manufacturing teams need to build a batch record review process that satisfies regulators, protects product quality and does not slow your business down. And because this is a live training session, attendees have the opportunity to ask Peter their most pressing questions directly, getting expert answers specific to their operations and challenges in real time.

Learning Benefits

• Understand the key elements of batch record review
• Recognize issues and apply remedies effectively
• Apply Good Documentation Practices
• Assess how new technologies are changing review processes
• Learn updated FDA, EU, and Canada regulatory expectations
• Use Quality Risk Management to prioritize critical aspects
• Track performance with useful metrics
• Identify early signs of degraded performance
• Avoid common compliance and business pitfalls

Regulations Covered

• US CFR Title 21, Parts 210, 211, and 600 series
• Health Canada regulations for pharmaceuticals and biologics, including Annexes 1, 2, 3, and 18
• EMA Eudralex Volumes 1, 2, 3, 4, 9, including Annex 13
• ICH Quality Guidelines Q1–Q11 across US, EU, Japan, and other regions

Who Should Attend

• Quality Assurance & Quality Control Personnel
• Auditors
• Regulatory Affairs Professionals
• Process Development Scientists & Managers
• Senior Management