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Overview

This program covers documentation and validation of HPLC systems. It is designed for those seeking employment in pharmaceutical drug manufacturing and drug analysis. Courses cover all aspects of pharmaceutical HPLC methodology, including method development and validation, instrument calibration, documentation and regulatory compliance.

Students must wear lab coats and safety glasses in the lab. These items may be purchased in the Seneca@York bookstore.

Information Session

New students are invited to attend an information session.

Career Opportunities

Career opportunities for graduates include employment in pharmaceutical quality control laboratories, quality assurance or research and development as laboratory technicians or specialists.

For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.

National Occupational Classification (NOC) - Government of Canada

The National Occupational Classification (NOC) provides a standardized language for describing the work performed by Canadians in the labor market. It gives statisticians, labor market analysts, career counselors, employers and individual job seekers a consistent way to collect data and describe and understand the nature of work.

Entry Requirements

Students must have a college diploma or university degree with a focus in Chemistry, Biology or Pharmaceutical Sciences. Students must also have basic HPLC work experience or equivalent.

English Proficiency

All Seneca College courses, except those specifically listed such as Modern Language courses, are taught in English. Evaluation in credit courses is based on your participation in classroom discussion, written assignments and examinations. For these reasons, it is crucial that you be able to function at an appropriate level in the English language.

We are interested in your successful achievement of academic outcomes and so make available a variety of learning opportunities in English. To be able to function at a post-secondary level, English training opportunities are available for those whose native language is not English. Refer to the English as a Second Language Program Information.

If English is your native language, but you have not completed a high school level of achievement in the course, English training opportunities are available. Refer to College/University Prep Information.

Prerequisites

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.


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Curriculum

Course Offering

Not all courses are offered each semester. Students may begin in any semester.

Recognition of Achievement Requirements

PFT869
Method Development
Availability
 

Prerequisite(s):

Work experience in HPLC or equivalent

This course introduces students to the fundamental concepts of analytical method development for both potency and impurity profiles. Topics include the nature of the sample, separation goals, sample preparation, reverse phase chromatography, ionic samples and reverse phase, reverse phase columns and ion pair chromatography. Analysis in the lab reinforces all theory. (Lecture and Lab)




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PFT871
Method Validation By HPLC
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This course deals strictly with HPLC method validation elements such as system precision, linear detector response, accuracy, limit of quantitation, limit of detection, ruggedness and robustness. (Lecture and Lab)




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PFT872
Instrument Calibration
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This course prepares students to calibrate all analytical balances, pH meters, UV/VIS spectroscopy, dissolution apparatus and the HPLC system. (Lecture and Lab)




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PFT873
Documentations and Compliance
Availability
 

This course explores the need for a proper documentation of method development, method validation and instrument calibration. This documentation must be done in compliance with principles of good manufacturing practice (GMP) and good laboratory practice. Students learn to write standard operating procedures (SOP) for the analytical instruments in order to achieve consistency. (Lecture only)




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Note: the following instrument courses cannot be challenged: PFT869, PFT871, PFT872.

If your degree is older than 8 years, you are not eligible for Transfer Credit. You can still earn a credit by applying through the Prior Learning Assessment (PLA) process.

Program Outcomes

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

  1. Calibrate components of an HPLC system and related apparatus
  2. Write Standard Operating Procedures (SOPs) for analytical instruments
  3. Perform method validation using an HPLC
  4. Perform analyses on pharmaceutical substances to determine potency and impurity
  5. Document method development, method validation and instrument calibration in accordance with regulatory requirements

Credit for Prior Learning

Prior Learning Assessment

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.

Transfer Credit (Advanced Standing)

Many students who enter Seneca College 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.

More Information

Please visit the Degree and Credit Transfer Office.

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 x22946


Olena Rodina
Part-time Program Coordinator
Olena.Rodina@senecacollege.ca
416.491.5050 x24115


Joanne Bonnet
Academic Program Manager
Joanne.Bonnet@senecacollege.ca
416.491.5050 x22528


Information Session

New students are invited to attend an information session.