Overview

The Pharmaceutical Quality Assurance ROA  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 ROA offers courses in quality assurance with an emphasis on compliance regarding sanitation and validation.

Entry Requirements

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.


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Curriculum

PFT840
A Practical Approach to QA System Design/Managemnt
Availability
 

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)




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PFT860
Qualification of Pharmaceutical Processes & Equip.
Availability
 

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)




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PFT911
Pharmaceutical Quality Assurance Basics
Availability
 

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.




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PFT955
Contamination Control in Pharmaceutical Manufac.
Availability
 

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, preparing for government inspection for compliance related to contamination control. (Lecture only)




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Program Outcomes

Upon successful completion of this ROA, students are able to:

  1. Design a quality assurance (QA) system and apply quality assurance/control measures to pharmaceutical manufacturing and packaging.
  2. Perform as a member of a quality assurance team.
  3. Control contamination during the manufacture of pharmaceutical products.
  4. Apply principles of microbiology and pharmaceutical chemistry to ensure safety and sanitation related to pharmaceutical manufacturing.

Completion

Recognition of Achievement

Upon successful completion of the program requirements, please submit a Request for Recognition of Achievement Form to the Faculty of Continuing Education and Training. There is no cost for this and your Recognition of Achievement will be mailed to you.

Program Contacts

Georgina Ioannou
Program Assistant
Georgina.Ioannou@senecacollege.ca
416-491-5050 ext.22946


Joanne Bonnet
Academic Program Manager
Joanne.Bonnet@senecacollege.ca
416-491-5050 ext.22528