Learn more about the academic programs we are delivering in Winter 2025. If you have any questions about part-time studies, please contact us.
The Pharmaceutical Quality Assurance Certificate of Completion focuses on basic principles of Total Quality Management and GMP (Good Manufacturing Practice) within the pharmaceutical industry. Quality and compliance go hand in hand. The Certificate of Completion offers courses in quality assurance with an emphasis on compliance regarding sanitation and validation.
Students are invited to attend an information session.
Ontario Secondary School Diploma or University/College Preparation: Grade 12 English, Chemistry, Mathematics and Grade 11 Biology are required. Mature students with work experience are considered on that basis, but may be advised to take College preparatory Chemistry, English, Biology, and Math.
Students who hold a diploma or degree from another country and have the above credits may directly enrol into the IPT program. You do not have to show your documents or write an admission test.
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.
This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. A) It focuses on the design of proper quality control/quality assurance systems to ensure the manufacturing of safe products and also to 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. B) It focuses on the 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. (Lecture only)
This course is an overview of the various aspects of validations, qualification/validation of pharmaceutical systems, processes and equipment. These processes received acceptance by the pharmaceutical industry in the late 1970s to ensure current Good Manufacturing Practices (cGMP) and product quality and integrity. Reliance upon end-product testing is insufficient to assure product quality. A high degree of quality of assurance arises only from good product and process design, validation and process controls. Validation concepts are applicable to both oral, solid dosage forms and sterile manufacturing pharmaceutical facilities. (Lecture only)
This course focuses on the concept of quality assurance and the contributions of quality assurance in a pharmaceutical organization. It takes a snapshot examination of common quality applications, tools, processes, and systems relevant to the pharmaceutical industry. Topics covered include: foundations of quality, basic statistical concepts and applications, document systems, SOPs, quality audit, validation, ISO standards, GMPs (FDA and HPFBI), product recall and complaints handling.
This course covers the principles of contamination control in pharmaceutical manufacturing. Topics include: basic microbiology, government regulations related to contamination control, microbial control of contamination in manufacturing, air filtration, ventilation, purification and control of water system and water testing for pharmaceutical manufacturing, production hygiene, employee health and hygiene requirements, microbiological testing of environment and interpretation of critical test results, evaluation of disinfectant and cleaning validation, self inspection and training of production employees for contamination control. (Lecture only)
Upon successful completion of this Certificate of Completion, students are able to:
Upon successful completion of the program requirements, please submit a Request for Certificate of Completion Form to the Faculty of Continuing Education and Training. There is no cost for this and your Certificate of Completion will be sent to you electronically.
Ramya Kottapalli
Program Assistant
Ramya.Kottapalli@senecapolytechnic.ca
416.764.0975
Jacqueline Bar
Manager, Academic Programs
Jacqueline.Bar@senecapolytechnic.ca
416.764.0984
For more information about this program, fill out the following form.
Students are invited to attend an information session.