n.BA.BT.QM.23HS (Quality Management) 
Module: Quality Management
This information was generated on: 21 May 2024
No.
n.BA.BT.QM.23HS
Title
Quality Management
Credits
2

Description

Version: 1.0 start 01 August 2023

 

Study Programme Biotechnology
Regulations Applicable RPO, 29 January 2008, School of Life Sciences and Facility Management Academic Regulations, 15 Dec. 2009, Annex for the Bachelor of Biotechnology degree programme
Module Type  
X Compulsory Module    Elective Module    Optional Module
Planned Semester 6th Semester
Module Coordinator Evelyn Wolfram
Telephone / E-Mail +41 (0)58 934 50 00 / evelyn.wolfram@zhaw.ch
Lecturer(s),
Speaker(s),
Associate(s)		 Various guest lecturers from industry on current topics
Entrance Requirements -
Learning Outcomes and Competencies Students will...
  • learn and understand methods to implement the basic concepts of the regulatory environment in the manufacturing of biotechnological products in the areas of pharmaceuticals, food and medical devices.
  • learn to apply risk analysis methods in the design of processes and/or products as a contribution to drug triad of quality, safety and efficacy.
  • understand the influence of the design, nature and suitability of equipment, materials and processes in Good Manufacturing Practice, with particular emphasis within the pharmaceutical and healthcare industries (NEM, medical devices, etc.).
  • understand and implement qualification and validation procedures in drug manufacturing.
  • understand special requirements involved in the quality assurance of biological drugs.
Module Content
  • Legally-binding regulations (GMP, pharmacopoeia, approval), relevant authorities in the international environment (Swissmedic,EMA, FDA etc.)
  • Sources, content, and terms of GMPs, standards and guidance documents
  • International harmonisation
  • Qualification and validation: Equipment, processes, cleaning, analytics
  • Modern quality management systems - contribution to sustainability and cost efficiency
  • Auditing/inspections in pharmaceutical companies (Swissmedic/FDA - Mutual Recognition Agreements)
  • Special regulations for biotechnologically produced active ingredients (‘biologics’)
  • Important quality certifications and labels
  • Detailed discussion of theory based on practical examples
Follow-up Modules -
Methods of Instruction  Lectures, case studies in groups, possibly also field trips
Digital Resources All resources, submissions of work, reference lists and video materials are on Moodle, or will be sent via email.
Lesson Structure / Workload  
 Contact Hours 28
 Guided Self-Study 4
 Independent Self-Study 28
 Total Workload 60
Classroom Attendance For excursions and guest lectures
Assessment Oral exam at the end of the semester 50%: Exam in groups

Coursework 50%: Case Study report and lecture or video
Language of Instruction  German
Comments -

 

Course: Quality Management
No.
n.BA.BT.QM.23HS.V
Title
Quality Management

Note

  • No module description is available in the system for the cut-off date of 21 May 2024.