Qualification and Validation in Biotechnological Industry

Department

Master's Program Biotechnology

Course unit code

BT_MA16_3_9

Number of ECTS credits allocated

1.0

Name of lecturer(s)

FH-Prof. Dr. Griesbeck Christoph, Mag. pharm. Krassnigg Andreas, Mag. pharm. Dr. rer. nat. Singewald Georg, MBA ETH

Mode of delivery

face-to-face

Recommended optional program components

none

Recommended or required reading

Renneberg, R.: Biotechnologie für Einsteiger, Spektrum Akademischer Ver-lag, 2006
relevant professional journals: BIOspektrum, Current Opinion in Biotechnology
legislative texts
databases: z.B. NCBI, Science Direct, esp@cenet

Assessment methods and criteria

Exam

Level of course unit

Master

Year of study

Fall 2025

Semester when the course unit is delivered

3

Language of instruction

English

Learning outcomes of the course unit

In this course, students acquire an overview of the legal framework condi-tions of biotechnological processes and respective facilities. They are famil-iarized in particular with the existing requirements regarding the approval of plants and processes as well as the principles and concepts of plant safety. Graduates know the legal conditions and the concepts of safety in genetic engineering. They are also aware of the basic and biotechnologically relevant property rights.

Course contents

• Regulatory principles
• Authorization and inspection of plants and processes
• Hazard analysis and critical control points (HACCP)
• Regulatory affairs, ISO standards, and GMP
• Quality risk management

Planned learning activities and teaching methods

lecture

Work placement(s)

none