Good Laboratory Practices

Course Code :1001WETGLP
Study domain:Biology
Academic year:2018-2019
Semester:1st semester
Contact hours:45
Credits:4
Study load (hours):112
Contract restrictions: Exam contract not possible
Language of instruction:Dutch
Exam period:exam in the 1st semester
Lecturer(s)Els Prinsen
Niko Celis

3. Course contents *

The student learns different attitudes and skills which are necessary to work in a lab conform the GLP guidelines. The courses are focused on training skills. guest speakers will contribute on specific topics.

 
Content
General laboratory skills and attitudes

  • Planning an experiment
  • correct working and range of acceptance/decline
  • keeping labnotes
  • Error on the measurements and which range is acceptable
  • safety rules
  • Correct use of lab instruments: from measuring cilinder over HPLC
  • Correct calibration and making calibration curves
  • data management

Industrial aspects

  • keeping labnotes and data management
  • patenting (US and EC guidelines)
  • Confidentiality
  • ELN- Electronic Lab Note book
  • GMP- Good Manufacturing Practice
  • GLP in pharma and biotech industry (Research, preclinical and clinical studies)
  • FDA (Food and Drug Administration) en EMEA (European Medical Evaluation Agency) : procedures for filing

Safety

  • Biosafety
  • Chemical safety
  • Standard operating procedures (SOP’s)

 
Certification and accreditation

  • ISO norms and accreditation