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An Introduction to GMP

Course Information

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

Scope

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 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 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.

Course Programme

09:30 Introductions and Scope of the Course
Understand the group requirements and the tutor’s background & experience
09:45 Background & 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 & 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

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