Note: All times mentioned are CEST. To get an impression, please take a look at the preview of this Training Course. Click here to have an overview of all dates for this training course.
Objectives
The Online Training is designed for people who have no or little knowledge of GMP.
You get to know the most important pharmaceutical regulations and their importance,
you get a basic overview of GMP requirements in pharmaceutical production, and
you become familiar with technical terms from the field of GMP and their meaning
Background
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements. The relevant European GMP regulations define the following prerequisites:
Commisson directive 2003/94/EC The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice ….
EudraLex Vol. 4 Good manufacturing practice (GMP) guidelines 2.9 Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them…..
In practice, many members of staff are often unaware of the contents and meaning of the different GMP requirements from Europe and US and their consequences for product quality. During this course, speakers with long-standing experience in the training of employees introduce and explain the most important elements of a pharmaceutical GMP system in an easy-to-understand way.
Target Group
The Online Training is directed to staff from the pharmaceutical industry having no or little experience with the current GMP requirements. This includes both employees who, after their vocational training, enter the pharmaceutical industry and experienced colleagues who work for the first time in a GMP-regulated environment. Participation is also recommended for personnel from suppliers who have to understand the quality requirements of their customers.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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Testimonials
Seminar Programme as PDF