Biotechnology

Das deutsch-polnische Double-Degree-Programm ist der einzige international kooperative Master-Studiengang in der Biotechnologie in Baden-Württemberg.
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Fakultät M+V

Modulhandbuch

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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
Credits and grades

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.

 
Responsible person

N. N.
Maximum number of participants 1
Recommended semester MBT 1
Frequency Annually (ws)
Usability

Master MBT
Lectures

Process Control Engineering

Type Lecture
Nr. M+V916
Hours per week 2.0
Content
  • The automation pyramid
  • Norms and regulations
  • The most relevant DCS systems
  • Sensors and actuators
  • Fieldbus systems
  • Controller Level
  • DCS Level

 
Literature

Literature:

  • Schildt, G.-H.; Kastner, W.: Prozeßautomatisierung; Springer, Berlin 1998
  • Polke, M. (ed.): Process Control Engineering; VCH, Weinheim 1994, ISBN-13: 978-3527286898
  • Urbas, L.: Process Control Systems Engineering; Oldenbourg Industrieverlag, 1st ed. 2012

Downloads:

  • Siemens: Manual of Siemens Simatic PCS 7 Getting Started, parts 1 and 2:
    http://www.pacontrol.com/siemens-manuals/Process-Control-System-PCS-7-Part1.pdf
    http://www.pacontrol.com/siemens-manuals/Process-Control-System-PCS-7-Part2.pdf
  • http://www7.informatik.uni-wuerzburg.de/fileadmin/10030700/user_upload/vorlesungen/ss03/lit_reg_aut_tech.pdf

 

Regulatory Affairs and Safety in Biotechnology

Type Lecture/tutorial
Nr. M+V582
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 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.

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#
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