GMP BASICS ATMP Edition
GMP BASICS ATMP Edition
Basic Level | Course | English | Pharma | 1 hour and 20 minutes
Corresponds to ½ day of teacher-directed learning
Description
This training will give you an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP intended for the market. The training will give you a good overview of the EU requirements in EU GMP Part IV and with the emphasis of understanding the reason behind different requirements.
The training is divided into 10 parts. Each part is a short video that ends with some questions. You have to pass all questions before you can continue. After the successful completion of all parts and the tests, you will receive your Certificate of completion.
Content
- The background to GMP for ATMPs and how authorities perform oversight
- Important elements of GMP such as barriers used to minimise mix-ups, prevent contamination, prevent employee errors
- Understanding the importance of cleanroom controls and behaviour to achieve a relevant Sterility Assurance Level
- Systems to ensuring right quality, with high degree of assurance and to facilitate investigations
- Creating GMP records
Course modules
0. Introduction
A short introduction to the training and the content. You can find the file to work with beneath Course material.
Duration: 2 minutes (Total duration of the course: 1 hour and 20 minutes)1. The what, why and how of GMP
The history and background combined with the most important reasons why GMP for ATMP products exists.
Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 1 hour and 20 minutes)
2. How authorities perform oversight
Introduction to the system of oversight for ATMP in the EU and how regulatory requirements translate down to specific facility instructions and procedures.
Trainer: Magnus Jahnsson
Duration: 12 minutes (Total duration of the course: 1 hour and 20 minutes)
3. Minimise risks for mix-ups
The first section of the 4 most important objectives of GMP. Here examples of requirements related to risks for mix-ups are covered.
Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 1 hour and 20 minutes)
4. Prevent contamination
The second of the 4 principles will introduce you to how the GMP requirements may prevent contamination with focus on required barriers.
Trainer: Magnus Jahnsson
Duration: 9 minutes (Total duration of the course: 1 hour and 20 minutes)
5. Microbiology and Sterility Assurance
More in-depth about microbiological contamination and the challenges with aseptic processing of ATMP products.
Trainer: Anna Lundén
Duration: 9 minutes (Total duration of the course: 1 hour and 20 minutes)
6. Minimise risks for errors
This third section of the 4 objective, training, written procedures and other GMP requirements related to how we as individuals contribute to quality are covered.
Trainer: Magnus Jahnsson
Duration: 6 minutes (Total duration of the course: 1 hour and 20 minutes)
7. Supplier controls, qualification and validation
In the fourth part of the objectives, you will learn more about some more systematic principles like supplier controls, qualification of equipment and validation of processes.
Trainer: Anna Lundén
Duration: 8 minutes (Total duration of the course: 1 hour and 20 minutes)
8. Facilitate investigations
Here the importance of traceability is described and you will learn more about how important it is that we create records and information to be able to perform investigations when needed.
Trainer: Magnus Jahnsson
Duration: 7 minutes (Total duration of the course: 1 hour and 20 minutes)
9. Creating records
This training module will give you an understanding about how to create records in a way that is compliant with GMP requirements and why Data integrity is important.
Trainer: Anna Lundén
Duration: 6 minutes (Total duration of the course: 1 hour and 20 minutes)
10. Summary
In this finale module of this GMP training specifically adapted to ATMP facilities we summarise how all the requirements make barriers to protect the patient. You will also here a few words about the differences when you move from a pre-GMP or research setting to a GMP environment.
Trainer: Magnus Jahnsson
Duration: 7 minutes (Total duration of the course: 1 hour and 20 minutes)
Course material
If you want to access the additional course material for this course, you need to sign in and have access to this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Anna Lundén
Anna Lundén is one of the founders of Key2Compliance® and works in close contact with the Life Science industry with both training and consultancy. She has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with both EU and FDA requirements and expectations.
Magnus Jahnsson
Magnus Jahnsson is Director Training and Courses at Key2Compliance. He has worked in the pharmaceutical industry for almost thirty years. During this time, he has worked both for the industry and for a regulatory authority. He has held positions in Research and Development, Manufacturing Operations, Quality Assurance and Regulatory Affairs, working both as a manager and a specialist.
Magnus is an experienced trainer and has given a number of lectures and courses on various aspects of GMP and regulatory compliance for ISPE and other organisations. He has lectured on four continents and is also an experienced GMP- and ISO-auditor.
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The course results in a diploma that shows that you have the skills required.
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Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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