Good Manufacturing Practice (GMP) - Basic Course Biotechnology
During the course the legal requirements for development, production and marketing of biopharmaceuticals will be taught.
Only with adequately trained and qualified personnel manufacturing license according to the applicable drug law may be requested, which is, for example, mandatory for Investigational Medicinal Products. The course will provide real-life GMP solutions which will be developed by an experienced instructor together with the trainees. The successful participation will be certified by the German Pharmaceutical Industry Association (BPI) and by the Gläsernes Labor Akademie (GLA).
Structures of authorities and associations, pharmaceutical law, e.g. public health authorities, national and international associations and communities, pharmaceutical regulation, EU law, German Drug Law; Quality Management; Premises; Equipment; Personnel; Hygiene; Documentation; Manufacturing: Basics, up-stream, down-stream, filling, finishing; Validation of manufacturing; Quality Control; Validation in Quality Control; Inspections and audits; Technology transfer in Pharmaceutical Industry; Investigational Medicinal Products; Clinical trials; Licence application; Computerized systems.
The qualification will comprise a total of 80 lessons which will be held from Thursday, 23 Aug 18 till Friday, 31 Aug 18, daily from 9:00 a.m. till 06.00 p.m., excl. Sunday, 26 Aug 18.
Natural scientists, PhD students and postdocs of natural scientific and medical degree programs; Technical assistants and trained laboratory assistants with professional experience.