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Introduction to Good Manufacturing Practice



Course Information

This course is designed to provide comprehensive guidance and practical help for those working to implement Good Manufacturing Practice.


Basic requirements for a pharmaceutical quality system (PQS) and an understanding of quality risk management (QRM) principles and their application, from current regulations and guidance.
An introduction to the Site Master File, roles and responsibilities, change control, document control, and key documentation for implementing Good Manufacturing  Practice (GMP) with regulatory inspection in mind. Common regulatory findings.

Who should attend?

People working in GMP including

  • R&D
  • Contract Manufacturing Organisations
  • Manufacturing
  • Quality Assurance
  • Auditing

Event Objectives: By the end of the course, delegates shall

  • Have an awareness of the basic requirements of GMP
  • Be aware of the EU GMP Rules and Guidance and relevant publications
  • Understand the roles and responsibilities associated with GMP
  • Be able to contribute to and maintain quality documentation
  • Have a basic understanding of product lifecycle and manufacturing
  • Understand the requirements of GMP in the QC laboratory context
  • Have a basic understanding of risk management and mitigation principles
  • Understand the need for quality systems and quality assurance activities
  • Be aware of common regulatory findings

Learning Outcomes: Delegates will be able to

  • Implement their role within GMP with confidence and knowledge of the principle requirements
  • Contribute effectively to the GMP quality system and their organisation’s compliance
  • Comprehend where their organisation’s activities sit within the larger GMP arena
  • Know where to seek further information within the published rules and guidance, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet.

Course Tutors

Louise Handy
Handy Consulting Ltd (Course Principal)

Recent Feedback

"Very good and engaging presenters."

CPD Points

7 Points

Course Programme

Please note timings may be subject to alteration

9.30 Introductions and Scope of the Course
Understand the group requirements and the tutor's background and experience. 
 9.45 Background and Regulatory Environment
Setting the scene, understanding the context, key legislation. 
 10.30 Principles of GMP
Key points and requirements. 
 11.00 Break 
 11.15 Personnel and Responsibilities
Management and staff, duties and accountabilities. 
 11.45 Overview of GMP Manufacturing
Basics of the product life cycle. 
 12.15 Lunch 
 13.15 Risk Management Workshop
Practical exploration of risk and mitigation activities. 
 14.30 QC Laboratories
Activities and practicalities.
 15.15 Break 
 15.30 Compliance
Quality Assurance and Self Inspection. 
 16.00 Question Time
A chance for questions on the practicalities of GMP. 
 16.30 Close of course 

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). 
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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