Modulhandbuch

Safety and Control in Biotechnology

Empf. Vorkenntnisse

 

Bachelor's level in control engineering, knowledge in process engineering

 

Lehrform Vorlesung
Lernziele

Students have obtained comprehensive knowledge of safety and process control in bioengineering.

 

Dauer 1 Semester
SWS 4.0
Aufwand
  • Lehrveranstaltung:60 h
  • Selbststudium/
    Gruppenarbeit:60 h

  • Workload:120 h
Leistungspunkte und Noten

Written examinations (60 min) and oral examination

The module grade is the product of the individual course grades multiplied with the respective C, divided by the total C of 4 for the module.

 

ECTS 4.0
Modulverantw.

N.N.

Max. Teilnehmer 1
Empf. Semester MBT 1
Häufigkeit jedes Jahr (WS)
Verwendbarkeit

Master MBT

Veranstaltungen Process Control Engineering
Art Vorlesung
Nr. M+V916
SWS 2.0
Lerninhalt
  • the automation pyramid
  • norms and regulations
  • the most relevant DCS systems
  • sensors and actuators
  • fieldbus systems
  • controller and DCS levels
Literatur
  • Schildt, H.-H.; Kastner, W.: Prozeßautomatisierung; Springer, 1998
  • Polke, M. (ed.): Process Control Engineering;VCH Weinheim 1994
  • Siemens: Manual of Siemens Simatic PCS 7, part 1 and 2
  • Available online:
    www.pacontrol.com/siemens-manuals/Process-Control-System-PCS-7-Part1.pdf
    www.pacontrol.com/siemens-manuals/Process-Control-System-PCS-7-Part2.pdf
Regulatory Affairs and Safety in Biotechnology
Art Vorlesung/Übung
Nr. M+V582
SWS 2.0
Lerninhalt

Students get to know the procedures and suppositions for working in the field of biotechnology, concerning regulatory affairs, biosafety and QM.

  • Biotechnology and Regulatory affairs I
  • Regulatory affairs II
  • Biosafety
  • QM in the industrial communityB

 

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.

Literatur

reading list:

  • Bill Griffiths. The role of the regulatory affairs function during mergers and acquisitions. Regulatory Rapporteur. February 2011.
  • Ronan Donelan. Good decision-making practice in the regulatory arena. Regulatory Rapporteur - Vol 10, No 6, June 2013.
  • Monique Garrett. The reality of regulatory leaders in pharma today. Regulatory Rapporteur - Vol 10, No 11, November 2013.
  • Satesh, M. K.: Bioethics and Biosafety, I K International Publishing House Pvt. Ltd 2008
  • Mike Page. The regulatory affairs function as a global development strategic partner. Regulatory Rapporteur - Vol 11, No 1, January 2014.

downloads:

http://www.raps.org/personifyebusiness/portals/0/documents/2010_sop_report.pdf

http://edma-ivd.eu/library/the-proposal-for-new-ivd-regulation#


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