Change Control Mastery: Managing GMP Changes Without Chaos
In a regulated pharmaceutical environment, change is inevitable — but it must be controlled. Change control is one of the most scrutinised elements of the pharmaceutical quality system, and one of the most frequent root causes of regulatory findings. Poorly implemented changes can trigger deviations, invalidate validation, or lead to MHRA citations.
This 3.5-hour instructor-led course equips QA, RA, validation, operations, and QPs to manage GMP changes confidently, consistently, and compliantly — from initiation to closure.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
Inspectors frequently raise findings when:
- Changes are made before approval
- Training is missed after SOP updates
- RA is not informed of licence-impacting changes
- Validation is incomplete or undocumented
- QPs are unaware of changes before batch release
This course prepares participants to avoid those pitfalls — and instead build confidence through control.
What does the course cover?
- Define what constitutes a GMP-relevant change
- Use structured risk assessments (e.g. FMEA, scoring matrices)
- Build cross-functional workflows with QA, RA, validation, and operations
- Decide when revalidation or regulatory filing is required
- Link change control with deviations, CAPAs, training and SOPs
- Avoid inspection findings through traceability, training, and robust documentation
- Present change control performance in metrics, dashboards, and QMR
Ideal for?
- Qualified Persons (QPs)
- Quality Assurance and validation professionals
- Regulatory Affairs teams
- Technical writers, SOP authors, and document control
- Operations leads and functional change owners
- Anyone contributing to or managing change control records
Benefits:
- Aligns with Annex 15, ICH Q10, and MHRA expectations
- Includes live case studies, checklists, and trainer walkthroughs
- Prepares staff to answer inspection questions on real GMP changes
- Supports QP release decisions and RA variation management
- Ideal for routine training, pre-inspection refreshers, or post-finding improvement
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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