GMP Basics 2.0 EN

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)

Additional material

There is no additional 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

The course results in a diploma that shows that you have the skills required.


All prices shown exclude VAT.


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