Course Code: TC-GMP-MR-03 | Version: 1.0 | Duration: 3.5 hours | Level: Intermediate to Advanced
Management review is where leadership either owns quality or merely watches slides go by. This course shows senior managers and quality leaders how to run reviews that turn data into real decisions.
What you will gain
- Understand management review as the engine of the quality system under ICH Q10
- Feed it honest, trended inputs that tell the truth
- Build a decision-ready review package with a RAG dashboard
- Drive outputs, actions and objectives that actually happen
Who this course is for
Senior management, quality leaders and anyone who prepares for or takes part in management review.
Prerequisites
A working knowledge of GMP and quality systems.
Course Overview
Management Review is the formal, scheduled process by which senior leadership evaluates the continuing suitability, adequacy, effectiveness and alignment of the Quality Management System (QMS) with strategic business objectives. It is one of the most powerful, and most frequently misunderstood, elements of the Pharmaceutical Quality System defined in ICH Q10.
When done well, management review transforms quality data into strategic decisions, connects operational performance to leadership accountability, and drives continuous improvement. When done poorly, it becomes an annual compliance exercise, a meeting that satisfies a regulatory checkbox while contributing nothing to the business.
This course equips all participants in the management review process, from data contributors to meeting chairs, with the knowledge, skills and frameworks needed to conduct management reviews that genuinely improve quality system performance.
Learning Objectives
On completion, learners will be able to:
- Define management review and explain its role within ICH Q10 and ISO 13485 quality management systems
- Identify all mandatory and recommended inputs to management review under applicable regulatory requirements
- Plan and schedule a management review programme, including frequency, format and participant responsibilities
- Prepare high-quality management review input reports, including meaningful metrics, trend analysis and recommendations
- Chair or actively contribute to a management review meeting, ensuring all agenda items are addressed substantively
- Document management review outputs, decisions, resource allocations, action items, to GMP standard
- Manage and track management review action items through to verified completion
- Demonstrate the link between management review and continuous improvement under ICH Q10
- Identify the most common management review failures and inspection findings, and how to avoid them
Audience
QA Managers, Site Leads, Quality Directors, MR Participants
Your certificate
On completion you receive a Truex certificate of completion, ready evidence of this training for your training file and for inspections.
Make management review the steering wheel of quality
Enrol now to give yourself or your team the skills, and the evidence of training, your quality system needs.
