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Introduction to Good Manufacturing Practice REMOTE LEARNING


RQA CPD Stamp

REMOTE LEARNING - this course will be delivered to you live online from the UK. 

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)

Recent Feedback

"Very good and engaging presenters."

CPD Points

7 Points

Course Programme 

 Please note this course will run in UK timezone.

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

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

Please note this course will run in UK timezone.

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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