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Post Graduate Diploma

Pharmaceutical Formulation & Validation Technology – Program Outline

Program Outline

Semester 1

GCCP01 – Good Manufacturing and Good Clinical Practices

  • The program covers 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.

PMVT01 – Pharmaceutical/Bio-Pharmaceutical Manufacturing Formulation & Validation Technology

  • Manufacturing technology, all types of process validation.
  • Drug formulation.
  • Manufacturing technologies.

STW005 – Scientific-Technical Writing

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

Semester 2

ETUF05 – Collective Validation

  • Collective validation & technology regulations
  • Equipment validation, Thermal validation, Utility validation, Computer & Facility Validation.

PMF001 – Manufacturing Formulation 1

  • Objectives of formulation, pre-formulation techniques, manufacturing formulation techniques, and related regulations.
  • Pre-formulation techniques.
  • Manufacturing formulation techniques.

PKV04 – Packaging Validation & Packaging Components

  • Packaging validation concept and packaging components.
  • Writing protocols.
  • Reports and master validation plans.
  • Regulatory requirements of packaging validation.

PRV03 – Process Validation

  • Process Performance Qualification And Continuous Process Improvements
  • Process validation concept, rationale, writing protocols, reports, and master validation plans.
  • Regulatory requirements of process validation.
  • Focus on real work industrial scenarios.

Semester 3

PMF002 – Manufacturing Formulation 2

  • Formulation mechanism for liquid, suspension, power, fermentation, filtration, media preparation.
  • Process analytical techniques and dosage evaluation.
  • Effective usage liquid, suspension, powder, fermentation, filtration, media preparation, and related mechanisms in pharma, biopharmaceutical, and medical device industries.

CLVM02 – Advance Cleaning Validation

  • Assessment of complex cleaning validation processes.
  • Development process of new equipment/product, worst case selection process.
  • Risk-based analysis for a technical overview.

PPRV05 – Advance Process & Packaging Validation

  • Complex processes and packaging validation techniques.
  • Risk-based analysis, technology transfer, feasibility studies.

Pharmaceutical Formulation & Validation Technology

Credential Awarded: Post-secondary Diploma

Duration: 26 Weeks

Program Intakes:

Batch StartAdmission Deadline
Intake 1September 20, 2021August 20, 2021
Intake 2March 14, 2022February 14, 2021

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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