Registration for Fall 2026 programs and courses is now open. Learn more about the academic programs we are delivering in Fall 2026. If you have any questions about part-time studies, please contact us.
The Pharmaceutical Regulatory Affairs and Quality Operations Program is a graduate certificate program offered on a part-time basis through the Faculty of Continuing Education and Training.
This program provides students with a basic understanding of the areas of regulatory affairs and quality operations within various industries, including pharmaceutical. Students are prepared for occupations involving drug or medical device submissions and quality assurance functions and roles. The issues of regulatory compliance both in Canada and in other areas of the world are covered.
You can enrol in courses that are part of this program as a declared or undeclared student. Program declaration is the process of identifying the program you plan to complete and graduate with.
Declared Students
Declaring your program helps ensure your academic record accurately reflects your educational goals and supports your academic progression toward a credential.
By declaring your program, you'll be able to:
Undeclared Students
If you have not declared a program, Seneca may not know which credential you are working toward. As a result, you may miss out on the important benefits that declared students receive. You can remain undeclared and continue registering for courses if you do not intend to complete a credential and do not require progress tracking, enhanced advising support or Convocation eligibility.
Declared Students: For details about the program and how to apply as a declared student, please visit Seneca's updated Pharmaceutical Regulatory Affairs And Quality Operations page.
Undeclared Students: Register for courses by visiting the curriculum tab to select your course(s), check out and pay using this website.
Declared Students: Course registration for the Winter 2027 term for the part-time Pharmaceutical Regulatory Affairs And Quality Operations program will move from this website to Seneca's Visual Schedule Builder (VSB) platform. You will be able to build your class schedule when open enrolment begins on Dec. 10, 2026. Watch your email for instructions.
Undeclared Students: Register for courses by visiting the curriculum tab to select your course of interest, check out and pay using this website.
If you haven't yet declared your program but wish to do so, more information will be available soon.
Please review "Important Information for New and Returning Students" on the overview tab before registering for courses.
Important: The curriculum for this program has changed as of the Fall 2026 Term. Please review the new curriculum below to confirm your courses, progression and graduation requirements before registering. For questions, contact theservicehub@senecapolytechnic.ca.
Admission to the program
PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission
This course is an introduction to biopharmaceuticals and the application of biotechnology to produce them. Emphasis is on the regulations affecting the development and manufacturing of biopharmaceuticals and how they differ from traditional pharmaceuticals. Topics include: basic principles of biotechnology, large scale biopharmaceutical manufacturing, major differences in the regulatory process between biopharmaceuticals and traditional pharmaceuticals, combination biologics and medical device biologics. Students also explore future technologies employed in the biopharmaceutical and biotechnology industry to develop novel products.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
Admission to the program
PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission
This course covers the cGMP's, how they came into being and their impact on Formulation and Manufacturing, including the importance of accurate documentation and validation of all processes. Pharmaceutical mixing - mixers, excipients and the principles of how products are mixed to provide good flowing granulations are covered. Solutions, ointments, cream preparation and packaging as well as new novel drug delivery systems (transdermal patches, aerosols, and sub-cutaneous implants) are discussed. Students have the opportunity to propose formulations for products and learn how to troubleshoot problem products using the knowledge they have gained.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
Admission to the program
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.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
Admission to the program
This course describes the role of the Regulatory Affairs department in a pharmaceutical organization and focuses on the "submission process" and the legal requirements that control the process for pharmaceuticals, Natural Health Products and Medical Devices. The regulatory requirements at the various stages in a drug product development from inception through CTD (Common Technical Document) Clinical stage and NDS (New Drug Submission) application to issuance of the NOC (Notice of Compliance) are examined. The control and submission parameters for Medical Devices are discussed.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
A clinical trial is a carefully planned and scientifically sound experiment. This course provides students with an opportunity to learn and understand the rationale of designing, conducting and successfully completing a clinical trial. Students gain understanding of drug action, metabolism and clearance.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This mandatory course for WIL students prepares students to job search for their co-ops/work terms. Students will reflect on their skills, attitudes, and expectations and evaluate and interpret available opportunities in the workplace. Self-marketing techniques using resumes, cover letters, cold-calls, and interviewing will be learned and students will learn the expectations, rules, and regulations that apply in the workplace with regards to social, organizational, ethical, and safety issues while developing an awareness of self-reflective practice.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in European countries, Japan and USA are examined as well as the regulations in a selected number of other geographic locations. Specification criteria and tests with drug substances and drug products are compared and the reasons behind regulations and controls are examined.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This course introduces students to the basic concepts in clinical research and the clinical trial regulatory environment in Canada.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This course provides students with an introduction to the use of pharmacoeconomic evaluations in health care. The course reviews issues and methods of assessing health care technologies and related programs. Techniques used in pharmacoeconomic evaluations are examined. The application of the assessment of health benefits relative to drug costs in the determination of clinical cost-effectiveness is studied. Procedures for reporting pharmacoeconomic data and critical appraisal of the pharmacoeconomic literature are also considered.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. It focuses on: 1) the design of a proper quality control/assurance system to ensure the manufacturing of safe products and satisfy regulatory authorities. All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product; 2) management of the quality assurance systems to provide sufficient and adequate records on all testing, distribution and all other procedures that must be in place.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
This course focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a Common Technical Document (CTD) New Drug Submission (NDS) Module 1 along with the overall plan for the compilation of a submission. There is a class presentation relating to policy application for submissions with possible practical application and possible suggestions for dealing with expected deficiency. Introduction to auditing and the Preapproval Inspection (PAI) for submission approval are discussed and an audit practical exercise performed.
Ancillary fees will be added at checkout for program-based courses. Fees will vary based on the number of course registrations. Learn more about ancillary fees for part-time studies.
Semester 1 prerequisite courses must be completed to be eligible to enroll in Semester 2 courses.