About This Course

It is a legal requirement that all staff members receive Good Manufacturing Practice (GMP) pharmaceutical training as well as regular updates thereafter. Whether you’re just starting out in the industry or you’re an experienced member of staff, this intensive and highly interactive three-day GMP pharmaceutical training course is designed to teach you all you need to know about the latest EU requirements for pharmaceutical GMP.

Covering key sections of the ever-changing EudraLex Volume 4, delegates will leave with a thorough understanding of the essentials of GMP. The most popular in Europe, our pharmaceutical GMP courses are known and respected all over the globe.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The origin and reasons for GMP legislation
  • Key EU, UK and U.S. GMP legislation
  • The practical interpretation of GMP expectations and best practices
  • EudraLex and PIC/S expectations
  • Premises, processes, products, procedures, people and GMP

Course Outline

  • Why we have pharmaceutical good manufacturing practices
  • EudraLex Volume 4 (a copy is provided and is used as the basis of this course)
    • Structure
    • Content
    • Application
  • Appreciation of what is important for patients
  • Developing safe medicines and where GMP fits in the lifecycle of a medicinal product
  • An understanding of global GMP and licensing requirements
  • ICH Q9: Quality Risk Management
  • Responsibility of management
  • Supplier assurance and oversight of supply chains
  • Facility design considerations
  • Key utilities such as water and HVAC
  • Validation, calibration and maintenance
  • Operating an effective PQS including taking a closer look at human error, deviations, change control and complaints
  • People and the importance of training and understanding
  • Good documentation design principles
  • Importance of packaging
  • Data integrity
  • Laboratory controls
  • Audits and self-inspections
  • Good distribution practices

We also provide:

  • Up-to-the-minute information on new pharmaceutical GMP initiatives and regulations
    • Key changes to global GMP regulations
  • Practical advice on dealing with the difficult areas of pharmaceutical GMP
  • Access to experts for opinion on your GMP concerns

Why Choose NSF

This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95 percent of delegates rating it very good or excellent. It also meets the entry-level GMP training requirement for our very popular pharmaceutical quality systems auditor/lead auditor training program.

Bring your questions and tap into the great experience from helpful tutors. In addition, this course offers:

  • Tutors with real credibility and experience to bring pharmaceutical GMP training to life with examples and real-life stories
  • Training designed to reach all learning styles and preferences
  • Detailed reference material to take away and to become instantly useful
  • An ideal starting point for our modular QP training program

Course Tutors

Course tutors will be selected from the following:

Samantha Clack - A working QP, lead auditor and QP trainee coordinator, Samantha has an up-to-date knowledge of GMP requirements and hands-on experience of how to implement and meet regulatory expectations.

Mike Halliday - Mike has over 30 years’ GMP experience covering every major dosage form.

David Waddington - David has broad experience in QA and manufacturing management, working with a wide range of different dosage forms for global supply including solids, liquids, sterile products, food supplements and natural products.