Jump to content

Introduction to Good Manufacturing Practice

CPD Accredited

Book now

Click below for Course dates/fees:

Remote Course

Course Information

This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks.

Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings.

Is this course for you?

Ideal for professionals engaged in GMP across various sectors, including:

  • Research and Development (R&D)
  • Contract Manufacturing Organisations
  • Manufacturing Units
  • Quality Control (QC) Laboratories
  • Auditing Roles.

What will you learn?

Event objectives -  by the end of the course, delegates shall:

  • Have an awareness of the basic requirements of GMP
  • Be aware of UK and 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, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet.

Tutors

Tutors will be comprised of (click the photos for biographies):

Rhona McAteer

Rhona McAteer

Associate Director, Tower Mains Ltd

View pop up

Rhona has been working in the pharmaceutical industry for over 30-years, initially in steriles QC microbiology in Northern Ireland before moving into pharmaceutical and medical device QA, as Manager, Quality Assurance and Regulatory Affairs for a global manufacturer. She then moved to a small start-up solid and liquid oral dose pharmaceutical manufacturing facility and as their QA Manager and implemented global PQS’. Finally moving to a global CRO as the Manager, Quality Assurance Early Clinical Research at a phase I site before coming to Tower Mains as a Principal Associate, and progressively through to her current position as Executive Director.

Her wealth of experience encompasses quality management systems, generation, implementation and monitoring for Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice, Good Clinical Laboratory Practice and Medical Devices.

For Tower Mains clients, Rhona provides unique specialisms in audit, training, and advice on a broad range of GMP/ GDP/ GCP / ISO topics and is the Subject Matter Expert on GCP/GMP/GDP and Medical Devices.

When not in the office Rhona is most likely to be found hanging out with her cat or the horde of strays she looks after in Northern Ireland, doing crafts or putting out the fires from her husband’s on-going barbequing obsession.

Programme

Please note timings may be subject to alteration.

Day 1

09:30

Introductions and Scope of the Course

Understand the group requirements and the tutor's background and experience.

09:45

Background and Regulatory Environment

Setting the scene, understanding the context, key legislation.

10:30

Principles of GMP

Key points and requirements.

11:15

Break

11:30

Personnel and Responsibilities

Management and staff, duties and accountabilities.

12:00

Overview of GMP Manufacturing

Basics of the product life cycle.

12:30

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.

16:15

Question Time

A chance for questions on the practicalities of GMP.

16:30

Close of Course

Extra Information

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.

CPD Points

7 Points

Development Level

Learn

  • Very knowledgeable on the subject and brought in useful real life examples. Good presentation style, especially when delivered remotely

  • Louise was clearly very well qualified to give this training. Her CV indicates she is an expert in her field. I enjoyed her anecdotes about her work. I enjoyed the workshop after lunch. The material was delivered clearly

  • I was looking for an introductory course and found this course fitted this description well.

Book now

Click below for Course dates/fees:

Remote Course
Back to list