Learn more about the academic programs we are delivering in Summer 2024. 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.
Students are invited to attend an information session.
Graduates from this program may pursue careers in the areas of Regulatory Affairs and Quality Operations. Career options include within the pharmaceutical, biotechnological, veterinary and cosmetic industries. Graduates find employment as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates.
For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.
*Canadian citizens or permanent residents educated outside of Canada must provide a World Education Services (WES) or ICAS Canada credential evaluation.
It is your responsibility to ensure that program requirements and course prerequisites as outlined are met. Prerequisites are included for your academic protection. Knowledge of the prerequisite material is assumed by your instructor and instruction will proceed accordingly. Students lacking prerequisites not only jeopardize their own ability to succeed but present unnecessary interruption. If you lack appropriate prerequisites (or Transfer Credit for the prerequisite course) you may be asked to withdraw or transfer to a more appropriate course with the risk of academic/financial penalty.
If you are interested in applying, please register for the free information session RAQ001. You will be emailed a Zoom video recording providing a program overview and an explanation of the admissions process.
After viewing the recording, if you wish to submit your application for consideration, upload all required documents here: Pharmaceutical Regulatory Affairs and Quality Operations Graduate Certificate.
Part-time Studies courses are being offered in either of the following four formats: Online, Flexible, In-person, Hybrid. Click Availability below to see current offerings.
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.
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.
Admission to the program
PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission
The focus of this course is on communication with peers and the regulatory agencies. Students learn the various kinds of competencies needed to prepare regulatory communications and transact the business of quality assurance by primarily examining the practices used to gather and communicate information and improve organizational effectiveness. Aspects of interpersonal communication, such as the use of interviews and meetings to gather information are explored.
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.
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.
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.
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.
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.
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.
Module 1 prerequisite courses must be completed to be eligible to enroll in Module 2 courses.
Upon successful completion of this program, students are able to:
This program is eligible for OSAP funding.
Course load is used by OSAP to determine funding options for programs.
If you are taking one to two courses at the same time, you may be considered for part-time student grants and loans.
If you are taking three or more courses at the same time, you may be considered for full-time student grants and loans.
To find out if you qualify and to learn how to apply, please visit the OSAP website.
For information on other awards and financial assistance, please see Financial Aid.
Earn college credits for what you already know.
Prior Learning Assessment is a method of assessing and recognizing learning that is equal to
college level learning, but has been gained outside a traditional classroom (through work
experience, volunteering, outside study, etc.). If you can prove that the knowledge you have gained
meets the outcomes of a Seneca course, then credit will be awarded.
How does the PLA process work?
Prior Learning is demonstrated through a "challenge" process. The process measures learning
through a variety of methods which may include tests, portfolio assessment, interviews,
demonstrations, essays, and work samples. The method used will be determined in consultation with a
Program Coordinator.
For more information and to determine if you are eligible for PLA, please call the Program
Coordinator.
The process may take from 6 to 8 weeks.
Note: Not all courses can be challenged. For more information go to PLA website or contact your Program Coordinator.
Many students who enter Seneca Polytechnic will have earned academic credits in post-secondary educational institutions which they may be able to apply toward completion of a Seneca College program.
Requests for Transfer Credit must be for a specific course and must be accompanied by an official transcript and course outline. A minimum grade of "C" (60 percent) is generally required for a course to be considered for Transfer Credit.
Download a Transfer Credit Request form. An official copy of your transcript and applicable detailed course outlines should be attached and submitted. Please note it may take 4 to 6 weeks for a Transfer Credit decision.
Please visit the Office of the Registrar.
Take your graduate certificate further
Seneca is recognized as a leader in pathways and offers a range of options to help you reach your educational and career goals.
As a graduate of this program, you may be eligible to pathway into a master's degree program at one of our partner institutions.
To qualify for a master's degree program, you may require a bachelor's degree as a prerequisite. Visit our Degree Transfer Guide to learn more and explore your pathway options.
If you have additional questions regarding pathways to, within and beyond Seneca, connect with our Academic Pathways team at 416.764.0399 or email academic.pathways@senecapolytechnic.ca.
After reviewing the Degree Transfer Guide, you can also book a virtual appointment to discuss your options in more detail with a dedicated Pathways Adviser.
When you meet all program requirements and become eligible for a certificate, diploma, or degree, you must inform the Registrar by completing a Graduation Application form and paying the graduation and alumni fee. Certificates, diplomas, and applied degrees are issued twice a year in the Fall (October), Spring (June) and Winter (February).
For further information including deadlines and fees, please visit the Convocation website or contact the Convocation Office at theservicehub@senecapolytechnic.ca.
A student will be eligible to graduate from a certificate, diploma, advanced diploma or graduate certificate program if they have achieved a minimum graduating GPA of 2.0.
A student will be eligible to graduate from a degree program if they have achieved a minimum graduating GPA of 2.5, which includes a minimum GPA of 2.5 in the courses in their main field of study and a minimum GPA of 2.0 in breadth courses.
A faculty of Seneca College may recommended a student for a certificate, diploma or degree only after the student has earned a minimum of twenty-five percent of the credit for that program at Seneca.
Afaf Mousa
Armed with a University degree from abroad and a Canadian College diploma, Afaf Mousa looked for a Seneca College graduate certificate program that would help her get a step ahead in her Canadian job search. She found the Pharmaceutical Regulatory Affairs and Quality Operations program to be just what she needed! Having completed eight of the required courses - including the two quality assurance oriented subjects - in the part-time Reg Affairs program, Afaf responded to a job posting on Seneca's Career Link website and was hired in a QA position! Afaf went on to complete the program (graduating in 2011) while employed as a QA specialist in a local pharmaceutical manufacturing firm.
Afaf encourages her colleagues to take Reg Affairs; she speaks of the highly educated students in the program and the fact that they are all mature, adult learners. She reports that the program is well structured, the faculty very helpful and the material well presented. The part-time nature of the program, she notes, makes it easy for those already working to improve their situation. For those wishing to find a job, she notes that the focus of the program on the regulatory environment, clinical studies, quality assurance, as well as pharmaceutical manufacturing are all vital to finding related employment in the pharmaceutical industry.
Maria Graziosi
Program Assistant
Maria.Graziosi@senecapolytechnic.ca
416-764-0964
Jeevaka Weerasinghe
Part-time Program Coordinator
jeevaka.weerasinghe@senecapolytechnic.ca
437-312-0360
Contact us via this form or using the phone number(s) below it.
Students are invited to attend an information session.