Good Manufacturing Practice (GMP) is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards.
This interactive and engaging course will provide you with an overview of GMP guidance, and upon completion you will have a clear understanding of the history of GMP, the relevant guidance, trends and recent findings, data integrity and the documentation involved.
This course can be booked on an individual or group basis. If you are interested in training for you or your organisation, please contact training@towermains.com.
✔ Understand the history of GMP
✔ Introduction to the regulatory environment
✔ Follow the guidance – ICH and EudraLex Vol 4
✔ Understand documentation, data integrity and ALCOA
✔ Follow the trends and recent findings
This course would be beneficial for individuals who are:
✔ New to GMP or require a refresher course
✔ Laboratory management who are considering the introduction of GMP
✔ Sponsors of product development who need to understand GMP requirements
✔ Research staff who wish to develop quality management systems based on GMP
✔ Engaged in the manufacture, processing, packing or holding of a drug product
✔ Indirectly involved in manufacturing i.e., senior management, IT.
1 day
The course is delivered to groups of up to 20 learners and broken down into four modules:
Topic 1: Introduction to GMP
- What is GMP and what is the need?
- When does it apply?
- Regulatory oversight
- Developments and reasons for change
Topic 2: The guidelines
- ICH
- EudraLex Vol. 4
Topic 3: GMP in real life
- Hot topics
- Data integrity
- Documentation
- Inspection findings
- What is new and incoming?
These modules consist of a mixture of presentations and interactive group exercises.
An electronic certificate of attendance will be issued to each participant.
If you are interested in booking a future course, please contact Erin Bell to register your interest.
Testimonials
“Rhona was a very good presenter. I have never enjoyed a GMP course – this was a first!”
“An excellent course, tailored beautifully to our requirements and delivered by a knowledgeable trainer!”
“Always good to hear the current trends and updates in GMP and this course delivered that.”
“Really lovely style, laidback, friendly, informative. Great tutor.”
