PHAMF-CT Pharmaceutical Manufacturing

Courses and Descriptions

Courses and Descriptions

(Click the course name to view the description of the course)
Recognition of Prior Learning (RPL)
In addition to Transfer of Credit from a recognized post secondary institution, other RPL processes are available for RPL courses. Click here for more information. For courses with no RPL, please check www.rrc.ca/rpl for additional contact information.
CHEM-1029Intro Chemistry
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This is an introductory course designed to refresh students’ basic chemistry and introduce them to the concepts and principles used later in the program. Starting with fundamental concepts such as the structure of atom bonding and nomenclature of simple molecules, the contents quickly move to more complex topics such stoichiometry, chemical equilibrium, properties of solutions, acids, bases and buffers. The practical component of this course ensures that students are comfortable in performing simple laboratory operations such as weight and volume measurements, solution preparation, and handling of laboratory samples.

COMM-1010Technical Communication 2
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This course develops communication skills necessary to function effectively in a scientific workplace.

Prerequisites:
COMM-1027Technical Communications 1
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This course develops writing skills necessary to function effectively in a scientific workplace.

MATH-1090Fundamentals of Technical Mathematics
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This course teaches students the applied mathematics required in the pharmaceutical manufacturing industry. Topics include scientific notation, exponential numbers, metric system, conversions between measured units, significant figures, percentage, ratios, proportions, liquid/solid measurements, dilutions, concentrations, basic algebra, and problem solving. Emphasis is on the metric system, in keeping with the standards in pharmaceutical manufacturing in Canada.

PHAR-1024Applied Biopharmaceutical 1
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This course emphasizes the theoretical and practical aspects of microbial fermentation. Participants will get hands-on experience setting up and monitoring biofermentors, as well as conducting practical experiments that include the effects of nutrient components on cell density, mixing, aeration, analysis in microbial system, aseptic techniques, and microscopy. Other topics relating to biofermentation such as basic microbiology, documentation, and environmental controls will be explained via PowerPoint presentations followed by group discussions. Approximately 60% of the time is spent in the laboratory and 40% is in the classroom.

PHAR-1025Intro to Liquid & Semi-Solid Dosage Form
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This course focuses on the concept of dosage form and its ramifications. Students will learn about different dosage forms, their classification, routes of administration, therapeutic applications, and general pharmacological aspects. In addition, they will learn about formulations and manufacturing processes with an emphasis on liquid and semisolid forms. Pertinent properties of liquid and semisolid systems such as viscosity, osmolarity, surface tension, transition point, etc. along with relevant chemical aspects such as polarity, pH, and partition coefficients will also be discussed.

PHAR-1026Workplace Safety in Pharmaceutical Manufacturing
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This course provides students with the basic knowledge required to work safely in a variety of science/technology-based workplaces such as laboratories or chemical manufacturing plants. The course will offer an introduction to potential health and safety hazards that may be encountered in such workplaces with emphasis on harm prevention and safe laboratory practices. Legislation related to chemical/biological work, such as the WHMIS system, is also covered.

PHAR-1232Pharmaceutics, Quality, Compliance
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This course delivers, through classroom lectures, the principles and application of good manufacturing practices in a pharmaceutical manufacturing environment. Major compliance areas such as good documentation, the importance of records, training, and good sanitation and hygiene practices will be emphasized. Students will be able to describe important aspects of premise design, construction, and maintenance and the impact that equipment can have in the prevention of product contamination and maintaining the quality of the product throughout the manufacturing cycle. The use of audit is described. The general organization of a pharmaceutical company including the types of products they produce is described. An overview of the relationship between regulatory agencies, inspection and pharmaceutical companies is explained. The difference between innovator drugs and generics and an explanation of a patent is included.

PHAR-1234Solid Dosage Production 1 (granulation)
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This course introduces the students to the fundamentals of “Compressed Tablet” manufacturing process.  The theory part covers a range of topics including preformulation and formulation studies, dispensing, milling, mixing and different methods of granulation.  Students will also learn different in-line/in-process control procedures.  The practical part of this course will provide an opportunity for the students to simulate staging a batch, perform dispensing and milling and mix the powder to specified homogeneity levels.  They then move on to use different methods to prepare granules of desired characteristics using high and low shear mechanisms and dry the granules to predefined moisture content.  Alongside, the students will prepare all batch records, SOPs and other required documentation and practice equipment set-up/cleaning/maintenance and troubleshooting.

PHAR-2003Chemistry Drug Compound & Form
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In this course, students apply their knowledge of chemistry learned in the first semester to investigate and understand the chemical nature of common excipients used in dosage form formulations. The relationship between molecular structures and relevant properties of different excipients will be explored and related to the functions of the individual component. The course is designed as a number of interactive sessions where students share information on assigned excipients or drug molecules and discuss their chemistries.

Prerequisites:
PHAR-2020Solid Dosage Production 2
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The focus of this course is tableting and coating. In the tableting part, the theory of compression is discussed in detail along with the practical aspects of equipment set up and operation, formulation factors affecting tableting, and understanding and troubleshooting tablet defects. Students also learn about a number of on-line tests used to monitor the compression process and evaluate the quality of the product. Students will manufacture batches of tablets using both direct compression and the granulation routes. In the coating part, an elaborate discussion of tablet coating is taken up. Students will learn about the coating process, different coating polymers, and how to troubleshoot formulation and process related coating defects. Students will use their tablet core batches to practice tablet coating, equipment set up and operation, and process monitoring. The last few sessions of this course are dedicated to the encapsulation process where students learn about capsules as a dosage form and the operational principles of the capsule manufacturing process.

PHAR-2024Applied Biopharmaceutical 2
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Applied Biopharmaceutical 2 is designed to provide students with the basics of downstream processing in biopharmaceutical manufacturing. Emphasis is placed on the purification fundamentals of recombinant protein therapeutics, protein chemistry, column chromatography, and various filtration techniques. Pharmaceutical cleanroom behavior and practice will be discussed.

Prerequisites:
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