PQA811 - Quality Assurance II

Outline information
Semester
Schools offering this subject
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
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecacollege.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).

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