Continuing education is essential in the broad field of medicinal products. Dr. Cora Büttner is currently participating in a two-part training by CONCEPT HEIDELBERG GmbH covering the following topics:

• GMP for medical devices
• Qualification and validation in the area of medical devices.

But why are these topics relevant for a pharmacist and Qualified Person (AMG) for medicinal products?

“Upon closer examination, it becomes clear that medical devices and medicinal products are two distinct worlds, with different regulations governing quality requirements, the approval process, and inspections by authorities.

Exactly these two worlds meet each other, if you combine a medical device with a medicinal product – to get a 'combination product'. Here the application system for the drug plays a very important role.

Combination products pose a challenge for us to meet the requirements of both product groups and find a pragmatic solution to reconcile all requirements. As a qualified person at the end of the manufacturing chain, we certify these products.

Thankfully, in-person training is now possible after a long period of virtual seminars. On-site training has the advantage of allowing for face-to-face discussions during workshops, Q&A sessions, and, of course, coffee breaks 🙂. Both trainers and trainees agree on the benefits of this format.”