Introduction to GMP
A introduction into the basic principles of Good Manufacturing Practices (GMP).
A introduction into the basic principles of Good Manufacturing Practices (GMP).
This introduction to GMP training is an accessible tool to help you gain knowledge and insights into the minimum requirements for producing a medicinal product. Complete with a guided tour through the cleanroom facility.
GMP is a set of principles and objectives to ensure medicinal products are manufactured consistently and to a standard appropriate for their intended use. These principles are in place to assure: Patient safety, Efficacy, Consistent high quality and Appropriate for intended use during the complete life-cycle of the medicinal product. The introduction to GMP training will cover all of the above considerations.
Dana Quaden – Quality Associate GMP at Medace
Dana Quaden is responsible for maintaining and improving the Medace’ Quality Management System according to the current cell therapy (GMP) legislation and regulations on a daily base. Dana provides guidance to the cell therapy clients with developing tailor-made quality documentation for the specific cell therapy processes, further development of manufacturing processes and trainings on general cleanroom activities.
Jessica Gerards – Quality Manager GMP at Medace
Jessica Gerards is specialized in the area of Regenerative Medicine development, with the focus on ATMP. Jessica ensures compliance with international quality standards and guidelines to accelerate the development of her clients’ products towards patients.
Contact Kurt Gielen
kurt.gielen@medacespace.com
Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP requirements.
Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.