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Introduction to Good Manufacturing Practice

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Programme

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 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)

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

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

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