ICH Q12: Advanced Pharmaceutical Product Lifecycle Management in Practice Training Course

Course overview

ICH Q12 provides a harmonised framework for management of post approval CMC changes more predictably and efficiently across the commercial lifecycle, using risk and science-based approaches and an effective Pharmaceutical Quality System (PQS).

The guideline introduces a set of practical tools and enablers, including risk-based categorisation of changes, Established Conditions (ECs), Post Approval Change Management Protocols (PACMPs), and the Product Lifecycle Management (PLCM) document, and explains how these connect to regulatory assessment and inspection expectations. 

This course translates Q12 into real-world execution for the delegates and explains to them how to define ECs without ‘over locking’ the dossier, how to set reporting categories based on risk and knowledge, how to design PACMPs that regulators can approve, and how to keep lifecycle documentation inspection ready while enabling continual improvement. 

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

Delegates will be able to:

• Apply ICH Q12 lifecycle tools to accelerate post-approval CMC change implementation while maintaining compliance and product quality
• Define and justify Established Conditions (ECs) to enable regulatory flexibility without over-locking the dossier
• Develop PACMPs with clear scope, studies, and acceptance criteria to improve predictability and reduce regulatory rework
• Use science- and risk-based approaches to categorise CMC changes and align reporting pathways across global regions (EU vs FDA)
• Build and govern the PLCM document as a living lifecycle tool linked to internal change control, ECs, and PACMP strategy
• Integrate ICH Q12 into the PQS (ICH Q10) using knowledge management, QRM, and change control to strengthen inspection readiness
• Apply Q12 through practical case studies and workshops covering site transfers, process optimisation, analytical changes, and frequent post-approval updates
• Understand Q12 implementation across FDA, EMA, MHRA, PMDA, Health Canada, and WHO, including legal and procedural differences by region
• Strengthen regulatory decision-making by recognising how assessors and inspectors interpret lifecycle data and apply 'flexibilities' in practice.

Who should attend

• Regulatory affairs and submission authors
• Quality assurance and pharmaceutical quality system owners
• Change control leads and QRM specialists
• MS&T, tech transfer, process development teams
• Analytical development, quality control, method lifecycle owners
• Supply chain, external manufacturing management specialist
• Quality agreements owners
• Program lifecycle management leads for marketed products

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