PQA712 - Introduction to Clinical Quality Assurance

Subject Title
Introduction to Clinical 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 CAPA; complaint-handling; 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 Clinical Research offered through the School of Biological Sciences and Applied Chemistry

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

1. Prepare Quality document templates (Standard Operating Procedures (SOPs)).
2. Define Quality Assurance and Quality Control
3. Apply Good Documentation Practices and quality principles to the development, investigation and generation of reports for quality scenarios.
4. Apply Good X Practices (GMP, GLP, GCP etc.)
5. Apply documentation requirements and standards.
6. Apply basic project management principles
7. Propose actions and remediation suggestions to various compliance issues.
8. Develop a strong understanding of Corrective Action and Preventive Action (CAPA) in order to apply it to real monitoring and auditing situations.

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.

Discrimination/Harassment
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@senecapolytechnic.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 Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.

Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.

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