Course Overview

  • “Well planned. Professional tutors. It has been a pleasure. Good with the group works and the social arrangements.”Mie Weibel / PEC, Denmark
  • “It is a fun and relaxed way of knowing much more about GMP.”Elma Snijder / Solvay, The Netherlands
  • “Up-to-date knowledge from (in) good presentations. Well built, easy to understand, good examples.”Tibor Erdös / Beckton Dickinson & Co, Hungary
  • “The standard of lecturers/presenters was excellent, very impressed with the quality and completeness of the material covered.”Gerrard Kemmy / Covidien, Republic of Ireland
  • “Superb, enjoyable and expertly delivered. Many thanks.”Doug Strachan / Emcor, UK

It is a legal requirement that all staff receive regular training in Good Manufacturing Practice. This course is designed to provide you with up-to-date knowledge of new and impending Good Manufacturing Practice regulations and current ‘hot topics’. Europe’s Most Popular GMP Course! In the last nine years, over 1000 delegates from all over Europe have attended this very popular course. This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95% of delegates rating it “very good” or “excellent”. This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Programme.

About This Course

It is a legal requirement that all staff receive regular training in Good Manufacturing Practice.

This course is designed to provide you with up-to-date knowledge of new and impending Good Manufacturing Practice regulations and current "hot topics."

Europe’s most popular GMP course!

  • In the last nine years, over 1000 delegates from all over Europe have attended this very popular course.
  • This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95% of delegates rating it “very good” or “excellent.”
  • This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Program.

Course Outline

  • Why we have good manufacturing practices
  • EudraLex Volume 4
    • Structure
    • Content
    • Application

A copy of EudraLex Volume 4 is provided and is used as the basis of this course.

  • A clear comparison of EU and FDA GMP requirements
    •  Areas of agreement
    •  Critical differences
  • Up-to-the-minute information on new good manufacturing practices initiatives and regulations
    •  FDA’s cGMP for the twenty-first century
    • Changes to EU GMP regulations…
      • Product Quality Review
      • Ongoing Stability Testing – reference samples and retention samples
    • ICH Q9: Quality Risk Management
  • Practical advice on dealing with the ‘difficult areas’ of good manufacturing practice
    • Change control
    • Deviations
    • Assessing the effectiveness of training
  • An understanding of how GMP is influenced by…
    • Premises
    • Processes
    • Products
    • Procedures
    • People
  • An appreciation of the critical good manufacturing practice issues for…
    • Solid dosage forms
    • Sterile products
    • Liquids/semi-solids
    • Packing operations
    • Computers
  • A panel discussion session to explore YOUR specific GMP problems

Course Tutors

Course tutors will be selected from the following:

Other Dates and Venues for This Course

  • 23-26 March 2015 | Manchester
  • 6-9 July 2015 | Dublin

This Course Offers Enhancement for the Following Career Paths

  • Good Manufactory Practices
  • Audits/Self-Inspections
  • Pharmaceutical Law/Regulatory Affairs

Register