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.

PHA.QC.QA.DIP

Pharmaceutical Quality Control & Quality Assurance

Credential Awarded: Post-secondary Diploma

Duration: 26 weeks

Program Intakes:

Intake 1	MAR 27th, 2023
Intake 2	SEP 04th, 2023

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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