Pharmaceutical Quality Systems (PQS) and ICH Q10 Implementation

Overview:

This webinar provides an in-depth, practical understanding of Pharmaceutical Quality Systems (PQS) and ICH Q10 implementation. Participants will learn how to apply ICH Q10 principles to strengthen their quality systems, improve risk management, and enhance inspection readiness. Using real-world examples, the session explains how PQS elements-such as CAPA, change management, management review, and process performance monitoring-work together to drive continual improvement and sustainable compliance. Attendees will leave with actionable strategies and tools to evaluate their current PQS and prioritize improvements aligned with regulatory expectations.

Why you should Attend:

If your PQS is not fully aligned with ICH Q10, you may already be at risk for unexpected FDA/Health Authority findings, repeat deviations, and ineffective CAPAs that never quite “stick.” This session will show you where typical PQS gaps hide, how regulators are viewing ICH Q10 today, and what you must have in place to avoid costly inspection surprises, rework, and potential supply disruptions.

Areas Covered in the Session:

• Overview of Pharmaceutical Quality Systems (PQS) and the ICH Q10 model
• Key elements of ICH Q10 and how they integrate with existing GMPs
• Role of PQS in lifecycle management and continual improvement
• Practical strategies to implement and strengthen:
• • CAPA systems
  • Change management
  • Management review
• Process and product performance monitoring
• Using risk management to prioritize PQS improvements and resources
• Aligning PQS with regulatory expectations and current industry trends
• Common PQS weaknesses observed in inspections and how to address them
• Roadmap for assessing your current PQS and planning phased implementation

Who Will Benefit:

• Quality Assurance (QA) Managers and Specialists
• Quality Control (QC) Managers and Supervisors
• Regulatory Affairs & Compliance Officers
• Manufacturing / Operations Managers and Supervisors
• Process Improvement / Continuous Improvement Professionals
• Validation, Engineering, and Technical Services personnel
• Pharmaceutical R&D and Tech Transfer professionals
• Site Quality Heads and Corporate Quality Leaders