With the start of the new year, we launched our new Good Manufacturing Practice (GMP) online course that covers the legal requirements and best practices for quality oversight on external manufacturing.
The GMP quality oversight course for European drug products is a self-paced online training solution for GMP quality professionals who are responsible for quality oversight of pharmaceutical contract manufacturing.
The course content is based on the GMP requirements as laid down in ICH Q9, Q10 and the EU-GMP Guide including Annexes. It ensures awareness and understanding of how a quality system is set up in an outsourced model.
This introductory course gives you and your team the knowledge to retain quality oversight in compliance with the international and EU Good Manufacturing Practice legislation.
Who is the GMP course for?
The Good Manufacturing Practice (GMP) online course has been developed in collaboration with quality oversight experts and translates the GMP framework into practice.
It is especially applicable for:
- Quality departments
- QMS teams
- Management of pharmaceutical and biotech companies
- Drug product development leaders
- Clinical study supply leaders
- CMC leaders
- and all others involved in quality oversight
It allows you to retain quality oversight in compliance with the International and EU GMP legislations and is the best choice for those who like the flexibility of online learning at their own pace and time.
What will you learn?
Role based GMP requirements and oversight elements are explained in three modules, based on a logical order of steps to take. These modules give insights and best practices in how oversight should be done in an outsourced module. This course is giving you the know-how needed to setup and execute quality oversight of contract manufacturing.
After completing the course you’ll know how:
- GMP is applicable to all roles involved in the manufacturing of (investigational) drug products, including external manufacturing/ CMO and other vendors
- to set up and manage compliance with quality standards for both the internal organization as well as the vendors
- complying to GMP and quality standards make processes efficient, accurate and reliable
- to ensure the safety of the subjects and patients by making sure the (investigational) drugs are consistently produced and controlled according to (GMP) quality standards by vendors
- to perform quality oversight on their production and control
- oversight elements such as vendor selection, quality visits and clear communication processes are done
After you have completed all the learning elements of this e-learning course, you will directly receive the GMP Certificate online.
Why learn with GCP Central?
Our self-paced online course is designed with the busy GMP quality professional in mind. It allows 24/7 online learning flexibility and gives you the vital GMP knowledge to be directly implemented into your daily practice.
Additionally, with our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.
The myGCP app offers easy access to the GCP training via smartphone, tablet, or desktop and can be completed on the go in your own time.
You can access your GCP certificate from the app dashboard, meaning that proof of compliance is with you all the time.
TAKE THE NEXT STEP
Learn everything you need to know to master GMP quality oversight for European drug products via this highly interactive, self-paced, and certified e-learning course. Visit the website and start your training today.