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Post Graduate Diploma

Pharmaceutical Quality Control & Quality Assurance – Program Outline

Program Outline

Semester 1

GCCP01 – Good Manufacturing and Good Clinical Practices

  • Concepts and requirements necessary for compliance with Good
    Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
  • GMP controls required to manufacture drug products in Canada,
    the United States and in many parts of the world.
  • Focus on real work industrial scenarios.

ILTP02 – Introduction to Laboratory Testing & GLP

  • Compliance with Good Laboratory Practice (GLP) for
    pharmaceuticals and biopharmaceuticals.
  • Address the most important laboratory technique.
  • Exposure and experience with all major pharmaceutical
    instruments.
  • GLP guidelines widely used in pharmaceutical and related
    sectors.
  • Understanding of instrumentations, calibration and the
    application of various instruments.

STW006 – Advanced Scientific-Technical Writing

  • Different types of technical writing.
  • SOPs, Communication Methods And Issues, Validation Report
    Writing, Testing Methods, CofAs, CAPA, Change Control, Gap
    Analysis, OOT, OOS, Deviation.

Semester 2

HPL004 – High Performance Liquid Chromatography (HPLC)

  • HPLC/DAD fundamentals and functionality, sample
    preparations and system setting-up.
  • Chemstation software, IQ, OQ and PQ, testing and analyzing
    data.
  • Troubleshooting and investigations.

HPD001 – HPLC Method Development and Method Validation

  • Method development and method validation using the HPLC /
    DAD.
  • Major industrial regulations in terms of developing and
    validating testing methods.

Semester 3

DIS003 – Dissolution and Dissolution Hands-on Training

  • Introduction to dissolution current testing practices, testing
    requirements, critical components, sample prep techniques,
    media preparation, sample testing, data analysis, report
    preparation, limitations, IQ / OQ / PQ, calibration,
    troubleshooting, maintenance.
  • Out of specification investigation.
  • Dissolution techniques, applications, USP apparatus,
    dissolution testing, report writing, calibration,
    troubleshooting.

GCT005 – Gas Chromatography (GC)

  • Gas chromatography history, concepts, carrier gas.
  • Testing requirements, critical components, sample
    preparation techniques.
  • Sample testing, data analysis, report preparation, limitations.
  • GC-FID – IQ / OQ / PQ, calibration, troubleshooting.
  • Maintenance, and out-of-specification investigation.

GCUV002 – GC Method Development and Method Validation

  • Method development and method validation using the GC /
    FID.
  • Major industrial regulations, in terms of developing and
    validating testing methods.
Pharmaceutical-QA-and-QC-Diploma
PHA.QC.QA.DIP

Pharmaceutical Quality Control & Quality Assurance

Credential Awarded: Post-secondary Diploma

Duration: 26 weeks

Program Intakes: 

Intake 1 May 23, 2022
Intake 2 Sep 26, 2022

 

Kindly Note

Due to COVID-19, all training classes have been moved online (live, interactive, and instructor-led) or onsite until further notice. Hybrid Learning Mode will be used for programs that include hands-on training (theory will be delivered online and hands-on training will be delivered on-site). Students who wish to receive onsite instruction may request the college. Please get in touch with us for more information!

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Program Outline

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