164.169 Quality Assurance and GLP/GMP
This course is in all assigned curricula part of the STEOP.
This course is in at least 1 assigned curriculum part of the STEOP.

2020W, VO, 1.5h, 2.0EC
TUWEL

Properties

  • Semester hours: 1.5
  • Credits: 2.0
  • Type: VO Lecture
  • Format: Distance Learning

Learning outcomes

After successful completion of the course, students are able to understand and to use methods and tools of quality assurance / qualicty control in the chemical laboratory and in a production environment. Particularly, they are able to calibrate and to validate analytical methds, and to estimate the uncertainty of analytical results. Furthermore, they know and understand the different quality assurance systems under which the work of analytical laboratories is to be performed in the various regulated and non-regulated environments.

Subject of course

Introduction to Quality Assurance (QA): Definition of quality, terms and concepts of QA; importance of QA in research and industry; necessity of QA in the regulated environment; cost-benefit analysis of QA measures; mathematical and statistical methods and tools of quality assurance; method validation; practical tools of quality assurance (control charts, (certified) reference materials, interlaboratory comparisons; ). Accreditation of testing and calibration laboratories and certification of production sites according to the relevant regulations (DIN, ISO, EN); audits and inspections in the laboratory or the factory; Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP).

Teaching methods

Conventional lecture course format with numerous real-world examples and discussion items.

Mode of examination

Oral

Additional information

The lecture course will be held in German language in the winter semester, and in English in the summer semester.

Lecture notes (copies of PPT slides) will be made available via TUWEL to enrolled participants.

Lecturers

Institute

Course dates

DayTimeDateLocationDescription
Wed09:00 - 09:1507.10.2020 virtual pre-discussion meeting via ZOOM (LIVE)Pre-discussion
Tue17:00 - 19:0003.11.2020 - 01.12.2020 Lecture course will be held through GoToMeeting (LIVE)Lecture course (via GoToMeeting)
Wed17:00 - 19:0004.11.2020 - 09.12.2020 Lecture course will be held through GoToMeeting (LIVE)Lecture course (via GoToMeeting)
Quality Assurance and GLP/GMP - Single appointments
DayDateTimeLocationDescription
Wed07.10.202009:00 - 09:15 virtual pre-discussion meeting via ZOOMPre-discussion
Tue03.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed04.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Tue10.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed11.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Tue17.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed18.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Tue24.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed25.11.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Tue01.12.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed02.12.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)
Wed09.12.202017:00 - 19:00 Lecture course will be held through GoToMeetingLecture course (via GoToMeeting)

Examination modalities

Oral exam (discussion), or preparation of a 'dossier' on a selected topic from the field of analytical QA/QC.

Course registration

Begin End Deregistration end
01.10.2020 00:00 31.10.2020 23:59 31.10.2020 23:59

Registration modalities

Registration for this lecture course via TISS.

Curricula

Literature

Lecture notes for this course are available.

As further reading, one of the two boks is recommended:
- E. Prichard, V. Barwick: Quality Assurance in the Analytical Laboratory (Wiley & Sons, 2007)
- E. Prichard: Quality in the Analytical Chemisty Laboratory (Analytical Chemistry by Open Learning) (Wiley & Sons, 1995)

Previous knowledge

Basic knowledge of analytical methofds and the analytical approach of problem solving.

Miscellaneous

Language

English