Pharmaceutical Quality Control & Quality Assurance – Program Outline
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.
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.
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.
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 Quality Control & Quality Assurance
Credential Awarded: Post-secondary Diploma
Duration: 26 weeks
May 23, 2022
Sep 26, 2022
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!