PQA811 - Quality Assurance II

Outline information
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Last revision date 2019-02-12 14:36:40.234
Last review date 2019-03-18 09:40:49.819

Subject Title
Quality Assurance II

Subject Description
Introduction to Quality Assurance provides guidance on the systematic processes used to ensure implementation of the principles included in Quality Assurance.  Topics cover the tools and approaches needed to establish a quality assurance system and operate a compliant pharmaceutical/medical device organization.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

  1. Explain the rationale for, importance and design of QA systems in the pharmaceutical industry.
  2. Determine the integrated systems needed to manage quality deviations.
  3. Apply QA principles to various aspects of drug fabrication and analysis.
  4. Apply QA principles to the conduct of  various types of inspections and audits used in the pharmaceutical industry
  5. Prepare a pre-inspection plan and criteria for closure.
  6. Solve quality-related problems experienced in the industry. 
  7. Analyze a QA systems failure.

Academic Integrity
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Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

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Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.