GMP Biotech Summer School - Good Manufacturing Practice Basic Course Biotechnology & ATMPs

Learning Goals:

After course completion, attendees will have a thorough understanding of GMP basics as needed for the manufacturing of Biopharmaceuticals and ATMPs. Thus, based on their individual background, they should be able to identify potential occupational fields in the industry and authorities dealing with GMP topics.

Content:

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 an industrial level. This face-to-face 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 of how regulatory requirements are transferred into practice. The course will include some workshop elements where trainees will develop GMP compliant solutions (e.g. risk assessments, equipment qualification) together with the trainer.

Target Audience:

The course is directed to natural scientists, PhD students and postdocs of natural scientific and medical degree programs who work in fundamental research, biotechnology or in research pharma companies with little or no experience in drug development.

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