Course Overview
This course deals primarily with regulatory controls, auditing/inspecting techniques which are applicable to any function of chemical/biopharmaceutical/nutraceutical and contract testing laboratories. Specific examples will cover auditing of certain aspects of operations for compliance with GMP, GCP and GLP.
Prerequisite(s)
- No prerequisites are required for this course.
Credits
0.0
- Retired
- This course has been retired and is no longer offered. Find other Flexible Learning courses that may interest you.
Learning Outcomes
Upon successful completion of this course, the student will be able to:
- Define FDA, EU & Health Canada regulations applied in chemica/biopharmaceutical/nutraceutical/Analytical testing and contract research laboratories.
- Identify the main audit cycle stages and inspection process.
- Outline the necessary techniques to plan, organize and conduct audits and inspections.
- Interpret the FDA viewpoint on specific aspects of auditing/inspecting for GLP, GMP and GCP compliance.
- Apply the methodology needed for writing effective audit/inspection reports.
- Utilize the systems required for following up on Corrective Actions resulted from Audits/inspections.
Effective as of Spring/Summer 2009
Programs and courses are subject to change without notice. Find out more about BCIT course cancellations.