2757 - Good Manufacturing Practice & Good Laboratory Practice
Course Description
Pharmaceutical and laboratory operations depend on Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). This GMP/GLP course teaches you the regulations and expectations of Health Canada HPFBI GMP/GLP and US FDA GMP/GLP and how they apply to the manufacturing, distribution and importation of pharmaceutical, radiopharmaceutical, biological and veterinary drugs. You'll learn effective Standard Operating Procedure (SOP) writing and GMP auditing and get valuable insight from guest speakers who work within the pharmaceutical industry.
Financial assistance may be available to eligible Ontario residents through the Ontario Bridging Participant Assistance Program (OBPAP) provided by the Ministry of Training, Colleges and Universities (MTCU). Please email scs.learnerservices@utoronto.ca for details.
Learning Outcomes
- Ability to work in a GMP/GLP-compliant environment.
- Know the importance of good documentation practices and record-keeping.
- Understand the purpose and reasoning behind GMP/GLP regulations and their practical application through key quality systems.
- Understand the Qualyty Assurance-GMP-Quality Control relationship.
- Acquire essential skills for effective SOP writing and GMP auditing.
This course may be applied towards the SCS Certificate(s) in
- Life Science Enterprise : Required Courses