PQA711 - Introduction to Quality Assurance

Outline information
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Last revision date 2018-07-20 11:50:17.4
Last review date 2018-07-20 11:50:48.63

Subject Title
Introduction to Quality Assurance

Subject Description
This subject 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; deviation management and SPC/SQC; complaint-handling and product recall theory; and training on GLPs, GMPs and the International 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 Change Control processes.
 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.

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. Prepare Quality document templates (Standard Operating Procedures (SOPs), Deviation Inspection Report, Change Control).
  2. Apply Good Documentation Practices and quality principles to the development, investigation and generation of reports for quality scenarios.
  3. Apply Good X Practices.
  4. Apply documentation requirements and standards.
  5. Propose actions and remediation suggestions to various compliance issues.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

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 Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.