Pharmaceutical Quality Control and Quality Assurance Diploma


Regulatory affairs clinical science pharmacovigilence clinical trial monitoring audits and inspections ethics & human protection

PHARMACEUTICAL QUALITY CONTROL AND QUALITY ASSURANCE

This comprehensive diploma program has been developed to meet the required skills for effectively performing duties in quality control, quality assurance, method development and method validation fields in Pharmaceutical/Biotechnology industry and/or for those who want to upgrade existing skills or obtain new skills. Each area of the study will be covered in an in-depth manner for both Pharmaceutical and Bio-Pharmaceutical sectors.

Course Highlights:

  • 26 weeks Program
  • Hands-on Training
  • Optional Job Assistance for co-op, internship and full-time opportunities within pharmaceutical and biopharmaceutical and related sectors

Program Starts

Fall   |   Spring   |   Summer   |   Winter

Admission Requirements

Minimum of Grade 12 Diploma. Minimum of Grade 12 Diploma with required science and math courses/Equivalent

Click Here for Domestic Applications and Click Here for International Applications

The program includes the following applications:

Good Manufacturing & Good Clinical Practices

This course will introduce the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for pharmaceuticals and biopharmaceuticals. It will prepare students to establish and document a system of GMP controls required to manufacture drug products in Canada, the United States and in many parts of the world. It focuses on real work industrial scenarios.

Introduction to Laboratory Testing & GLP

This course will introduce the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP) for pharmaceuticals and biopharmaceuticals. It will address the most important laboratory techniques. Students will also get exposure and experience with all major pharmaceutical instruments. It focuses on real work industrial scenarios.

Dissolution & Dissolution Hands-on Training

This course will introduce dissolution current testing practices, testing requirements, critical components, sample preparation techniques, media preparation, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

High performance Liquid Chromatography (HPLC)

This course will introduce HPLC theory, components, testing practices, testing requirements, sample preparation techniques, mobile phase preparation, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

Gas Chromatography (GC)

This course will introduce gas chromatography history, concepts, carrier gas, testing requirements, critical components, sample preparation techniques, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

HPLC & UV for Dissolution: Method Development & Method Validation
p>This course will introduce how to initiate and perform method development and method validation using the HPLC /UV Spectrometer and the Dissolution Apparatus. It will cover major industrial regulations in terms of developing and validating testing methods.

GC & UV Spectrometer: Method Development & Method Validation

This course will introduce how to initiate and perform method development and method validation using the GC /UV Spectrometer. It will cover major industrial regulations, in terms of developing and validating testing methods.

Advanced Scientific Technical Writing

This course will introduce different types of writing and compiling scientific documents in QC and QA areas: SOPs, communication methods and issues, method validation reports writing, method validation protocols writing, dealing with batch records, auditing reports, investigations, and real work industrial scenarios.

Program Highlights:

  • Good Manufacturing & Good Clinical Practices
  • Introduction to Laboratory Testing & GLP
  • Dissolution & Dissolution Hands-on Training
  • High-performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • HPLC & UV for Dissolution: Method Development & Method Validation
  • GC & UV Spectrometer: Method Development & Method Validation
  • Advanced Scientific-Technical Writing

Job Opportunities:

Technologists, Raw Material Chemists, Finish Product Chemists, Stability Chemists, R&D Chemists Scientists, Calibration Chemists, Document Reviewers, Laboratory Coordinators, Trainers, SOP Writers, Auditors, Supervisors and Managers.

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