Good Laboratory Practice
A workshop offered by the Bonn Graduate Center
Good Laboratory Practice (GLP) is a quality system concerned with the organizational
process and the conditions under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded, archived and reported. In this workshop, you will learn more about GLP principles, their role in data integrity, and their importance for trustworthy data as crucial part of the development process.
In-person Workshop
Thursday, March 5, 2026
9:00 a.m. - 4:30 p.m.
Friday, March 6, 2026
9:00 a.m. - 12:00 p.m.
Trainer
Dr. Simon Pflug
Language
English
Location
Alte Sternwarte
Poppelsdorfer Allee 47*
Target Group
Doctoral students and postdocs
Track(s)
Research, Business and Organizations
Certificate
12 units are applicable within the Doctorate plus or Careers plus certificate
* The premises have limited accessibility. Please contact us if you need assistance.
Description
GLP is regulated worldwide in different laws and regulations (the predicate rules) and
builds the bridge between university research and (regulated) industrial research. Studies
conducted under GLP focus on safety aspects of new compounds like chemicals,
pharmaceuticals, pesticides, and food additives.
The purpose of part 1 of this workshop is to promote the understanding and knowledge of GLP principles, their role in data integrity, and their importance for trustworthy data as crucial part of the development process. All phases of a GLP-study, including planning, conduct, reporting and archiving, will be discussed. In addition, requirements concerning qualified equipment, validation of computerised systems as well as good documentation practice will be addressed. Moreover, we will highlight the difference between a good and a bad quality culture and the importance of critical thinking and risk management, a core process in every regulated pharmaceutical company.
During part 2 of the workshop we will make a step beyond the lines of GLP into the world
of clincial development and GCP and briefly look at Medical Devices and Medical Device
Software, an emerging topic during clinical drug development.
The workshop is designed for those who wish to know more about regulated industrial
research. It provides an opportunity for beginners to build their competencies in that area
and to actively engange with an experienced subject matter expert on Electronic
Records-Electronic Signatures (ER-ES) regulation.
Content
- GLP basics (definitions, principles, regulation)
- Main phases of a GLP study, including multisite studies
- Roles and responsibilities in a GLP test facility
- Data Integrity basics, including ALCOA++ principles
- Introduction into clinical development and Good Clinical Practice (GCP)
Creditable for the Micro Credential 'Research Ethics & Integrity'
Micro Credentials for doctoral students offer the opportunity to systematically add key future skills to your professional expertise. You can apply for a Micro Credential if you successfully complete at least four workshops from one area of expertise.
Contact
Bonn Graduate Center
Address
Alte Sternwarte
Poppelsdorfer Allee 47
53115 Bonn
More Workshops?
Have a look at further workshops offered in our Doctorate plus program this semester.
Also see
Certificate Doctorate plus
Acquire the Doctorate plus Certificate in one of our three career tracks and apply for an 'Add-on' in your track (job shadowing or career coaching).
E-Training
With our on-demand e-training courses, you can continue your education at your convenience.
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