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PQA711 - Introduction to Quality Assurance

Corequisites:

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

This course focuses on the concept of Quality Assurance/Quality Control, planning and contribution of the Quality Assurance team in an organization. Topics covered include QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; auditing theory; process deviations and SPC/SQC; complaint-handling and product recall theory; and detailed training on GLPs, GMPs and the ISO Quality Standards.
Students gain significant "hands on" experience in document reviewing and SOP writing/reviewing as well as case study work in process deviation and audit investigations. These skills were intentionally built into the program to provide students with meaningful QA skills that can be applied to their employment activities without a large training investment on behalf of the company who accepts them.


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Contacts

Mary
Program As
cherry.langlois@senecacollege.ca
416491505022523