Learn about the principles of Good Manufacturing Practice (GMP), the legal requirements, and best practices for effective and efficient GMP Quality Oversight on external manufacturing.
LEARNING OBJECTIVES
- Awareness that GMP is applicable to all roles involved in the manufacturing of (investigational) drug products, including external manufacturer / CMO and other vendors
- Setting up and managing compliance with quality standards for both the internal organization as the vendors
- Complying to GMP and quality standards makes processes efficient, accurate, and reliable.
- 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
- Understand how to perform quality oversight on their production and control.
- Understand oversight elements such as vendor selection, quality visits, and clear communication processes
DESCRIPTION
Online GMP Training. The Introductory GMP Quality Oversight Course for European Drug Products is the self-paced online training solution for GMP quality professionals who are responsible for quality oversight of pharmaceutical contract manufacturing and need to be aware of the GMP requirements as laid down in ICH Q9, Q10 and EU-GMP Guide including the Annexes. It ensures awareness and understanding how a quality system is set up in an outsourced model.
This training is applicable for the Quality department, the QMS team, 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.
This course has been developed in collaboration with Quality Oversight experts and translates the GMP framework to practice. It gives you the tools and examples to directly implement the knowledge in your daily practice. This course will support pharmaceutical and biotech companies in the setup and execution of Quality oversight of contract manufacturing.
The GMP Quality Oversight training includes one year of access to online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.
• GMP certificate
• Efficient and interactive learning
• Optimal mix: online modular training and daily GMP practice in an instructor-led classroom session
The program of the classroom session is tailored to the needs of the attendees (maximum 20) and allows interaction. You are challenged to apply your GMP knowledge to solve practical case studies. You will exchange knowledge and experiences with your peers and have in-depth discussions with the trainer Sandra van Londen to maximize your learning experience.
