Knowing and applying the Good Manufacturing Practice (GMP) regulations is one of the key elements in the manufacture of medicinal products for clinical trials and on industrial level.
This Course concentrates on GMP requirements regarding biopharmaceutical and Advanced Therapy Medicinal Products (ATMP) manufacturing.
During the Course the most important elements of GMP will be explained in an easy-to-understand way with reference to the relevant GMP regulations and examples how regulatory requirements are transferred into practice.
The Course will include some workshop elements where trainees together with the trainer develop GMP compliant solutions (e.g. risk assessments, equipment qualification).