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 examination (multiple choice test) will be certified by the German Pharmaceutical Industry Association (BPI) and by the Gläsernes Labor Akademie (GLA).
Topics
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.
Duration:
The qualification will comprise a total of 90 hours which will be held during 5 weekends (i.e. on Fridays from 2:00 p.m. till 06.00 p.m., on Saturdays from 09:00 a.m. till 06.00 p.m., on Sundays from 09:00 a.m. till 02:00 p.m).
Size:
The course is limited to a maximum of 20 participants and will only take place with a minimum of 10 attendees. Due to organizational reasons, an early registration is recommended.
Target Audience:
Natural scientists, PhD students and postdocs of natural scientific and medical degree programs; Technical assistants and trained laboratory assistants with professional experience.
Prerequisites:
Laboratory experiences are advisable.
Course fees:
1.995,00 € per participant excl. VAT.
Further information:
Dr. Uwe Lohmeier per E-Mail: u.lohmeier@bbb-berlin.de