Testkurs für Christian

module no.: MBT-12
          course: Regulatory affairs and safety in biotechnology

                                                                     lecture | 2 SWS, 2 C

                                                                         semester MBT 12

                                                           K60 (written exam 60 min)


lecturer(s):

Dr. Thomas Brandstetter, Dr. Ralf Hess


module:

Safety and control in biotechnology


Language of instruction:

English


prerequisites:

Learning outcomes:

Students get to know the regulatory systems and safety management when dealing with biological agents.


type of instruction:

Lecture


methodology:

Seminar lecture with exercises


contents:

·        Biosafety and biosecurity survey

·        Biosafety level guidelines

·        Authority management

·        DIN 13485, DIN 14971 (Risk assessment), DIN 17025

 

reading list:

·        Satesh, M. K.: Bioethics and Biosafety, I K International Publishing House Pvt. Ltd 2008

·        Latest edition of respective laws and regulations


downloads:

·        http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf


Students will be introduced in the different areas of biotechnologies. Within this for designing biodevices or executing procedures for bioanalysis, nowadays an enlarged understanding for regulatory affairs, IVD (in-vitro diagnostic) guidelines is getting mandatory. In addition to that aspects to biosafety and overall quality management has to be considered for commercial bioengineering.


Abstimmungskrs für die Physik-Dozenten der Hochschule Offenburg