Good Laboratory Practices

Course Code :1001WETGLP
Study domain:Biology
Academic year:2017-2018
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.

 

 
contains
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