Introduction to GMP and Quality Systems

Gain essential Good Manufacturing Practice (GMP) and Quality Management System (QMS) skills to succeed in regulated Life Science industries.

New to the regulated Life Science industry?
This one-day course gives you the essential tools to understand and apply GMP and Quality System (QS) requirements across Pharmaceuticals, Medical Devices, and In Vitro Diagnostics.

Whether you’re stepping into production, quality, or a supporting role, this course helps you hit the ground running with a clear grasp of compliance expectations.

Learning objectives

• Understand the regulatory landscape for GMP and ISO 13485, and how it applies across pharma and medical devices.
• Gain confidence in key terminology and learn to navigate applicable guidelines and authority expectations.

Course outline

The course covers:

• GMP Origins & Evolution
  Understand the patient-driven history and why quality matters.
•  Regulatory Oversight
  Learn how EU and US authorities inspect and enforce compliance.
• Requirements Overview
  Get a snapshot of pharma and medical device regulations including ISO 13485.
• GMP Compliance Essentials
  Focus on manufacturing risks and how to minimise them.
• Validation & Qualification
  Grasp the basics of equipment and process validation.
• Documentation & Data Integrity
  Learn how to write SOPs, record data correctly, and ensure integrity.

Who should attend

Individuals new to regulated Life Science sectors, professionals across:
Quality, Production, QC, Laboratory, Purchasing, Logistics, Technical and maintenance roles,
as well as Consultants, Contractors and Suppliers entering the industry.

Prerequisites

No prerequisites.
However, if you already have basic GMP/QS experience, consider an advanced course to maximise your learning.

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