GMP Basics 2.0 EN
GMP Basics 2.0 EN
Basic Level | Course | English | 52 minutes
Corresponds to ½ day of teacher-directed learning
Description
GMP BASICS is a Convenient, flexible and verifiable online training. It is a general training in Quality Systems for the Life Science industry based on the regulations and guidelines for Pharmaceuticals and to some extent, also Medical Devices.
This training has been developed by Anna Lundén, Key2Compliance® . The films are animated and designed to enhance understanding and perception of the presented concepts and presented by professional speakers.
The training is divided into 8 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 completions.
Content
- The background to GMP and Quality Systems and how authorities perform oversight
- Important elements of GMP and quality systems such as barriers used to minimise mix-ups, prevent contamination, prevent employee errors
- Systems to ensuring right quality, with high degree of assurance and to facilitate investigations
- Creating GMP and Quality Systems records
Course modules
1. The what, why and how of GMP and Quality Systems
The history and background combined with the most important reasons why GMP exists.
Trainer: Animated training
Duration: 5 minutes (Total duration of the course: 52 minutes)
2. How authorities perform oversight
Introduction to the system in EU and US for oversight of Lifes science industry
Trainer: Animated training
Duration: 9 minutes (Total duration of the course: 52 minutes)
3. Minimise risks for mix-ups
The first section of the 4 most important principles of GMP. Here examples of requirements related to risks for mix-ups are covered.
Trainer: Animated training
Duration: 5 minutes (Total duration of the course: 52 minutes)
4. Prevent contamination
The second of the 4 principles will introduce you to how the GMP requirements may prevent contamination.
Trainer: Animated training
Duration: 7 minutes (Total duration of the course: 52 minutes)
5. Minimise risks for employee errors
This third section of the 4 principles, training, written procedures and other GMP requirements related to how we as individuals contribute to quality are covered.
Trainer: Animated training
Duration: 6 minutes (Total duration of the course: 52 minutes)
6. Ensuring right quality, with high degree of assurance
In the forth section, you will learn more about some more systematic principles like qualification of equipment and validation of processes.
Trainer: Animated training
Duration: 7 minutes (Total duration of the course: 52 minutes)
7. 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: Animated training
Duration: 5 minutes (Total duration of the course: 52 minutes)
8. Creating GMP and Quality Systems records
The last 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: Animated training
Duration: 8 minutes (Total duration of the course: 52 minutes)
Course material
There is no additional course material for this course.
Notes
If you want to save your notes for this course, you first need to purchase it and be signed in.
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
Animated training
This training has been developed by Anna Lundén, Key2Compliance® . The films are animated and designed to enhance understanding and perception of the presented concepts and presented by professional speakers.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
Save time
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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