Pharmaceutical Quality System (PQS) Mastery: From Structure to Continous Improvement
A well-functioning Pharmaceutical Quality System (PQS) is essential for compliance, operational excellence, and the safety of patients. But it’s not enough to just have a QMS — it must be used, measured, and improved across all departments and sites.
This 3.5-hour instructor-led masterclass dives into how to build and manage a Pharmaceutical Quality System that meets ICH Q10 and EU GMP Chapter 1 requirements, supports QP batch release, and drives true continual improvement.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
In the world of pharmaceutical operations, regulatory compliance isn’t just about documentation — it’s about daily discipline, operational awareness, and consistent behaviours across every shift. The Application-Based GMP/GDP for Frontline Staff course delivers a hands-on, half-day learning experience designed for warehouse professionals, production operators, junior QA/QC staff, and line leaders working in GMP and GDP environments.
This 3.5-hour instructor-led session provides essential knowledge and practical skills aligned with MHRA inspection expectations and UK regulatory requirements for MIA, MIA(IMP), and GDP-licensed facilities.
What does the course cover?
- The four core elements of ICH Q10: CAPA, Change Control, Risk Management and Management Review
- How to implement these in a connected, functional system
- Signs of systemic PQS failure — and how to repair them
- Metrics that reflect system health and maturity
- Tools for aligning global and multi-site PQS with central governance
- Roles of QA, QPs, site leadership and corporate quality in PQS ownership
- How to prepare for inspection with confidence — not chaos
- Strategies for embedding a culture of quality, not just procedural compliance
Ideal for?
- QA officers and managers
- Qualified Persons (QPs)
- Compliance leads and audit managers
- Production and QC leaders
- Corporate Quality directors and global QMS managers
- Anyone involved in designing, running, or improving a PQS
Benefits:
- Complies with EU GMP Part I, Chapter 1 and ICH Q10 principles
- Includes PQS maturity model, audit tools and governance templates
- Encourages critical thinking and proactive management
- Improves data-driven decision-making and cross-functional collaboration
- Supports sustainable, inspection-ready operations
pharmaceutical quality system training, PQS mastery, ICH Q10 course, GMP quality system improvement, CAPA and change control, quality management review training, QMS audit preparation, pharma QMS metrics, EU GMP Chapter 1 training, QP quality system support
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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