Biotechnology

The German-Polish Double-Degree Program is the only internationally cooperative Master's program in biotechnology in the state of Baden-Württemberg.
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M+V Department

Modulhandbook

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Safety and Control in Biotechnology

Prerequisite

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

 
Teaching methods Lecture
Learning target / Competences

Students have obtained comprehensive knowledge of safety and process control in bioengineering.
Duration 1
Hours per week 4.0
Overview
Classes 60
Individual / Group work: 60
Workload 120
ECTS 4.0
Requirements for awarding credit points

Regulatory affairs and Safety in Biotechnology: written examination, 60 minutes, weighted 50%

Process Control Engineering: written examination, 60 minutes, weighted 50%
Credits and grades

 

 
Responsible person

Professor Dr. rer. nat. Christiane Zell
Recommended semester 1
Frequency Annually (ws)
Usability

Master MBT
Lectures

Regulatory Affairs and Safety in Biotechnology

Type Lecture
Nr. M+V2502
Hours per week 2.0
Content

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 community

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.

 
Literature

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#

Process Control Engineering

Type Lecture
Nr. M+V2503
Hours per week 2.0
Content

The course is structured as follows:

  • the automation pyramid
  • norms and regulations
  • the most relevant DCS systems
  • sensors and actuators
  • fieldbus systems
  • controller and DCS levels
Literature
  • 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


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