Pharmaceutical & Biotechnology Advanced Diploma – Program Outline

Program Outline

Semester 1

GCCP01 – Good Manufacturing and Good Clinical Practices

  • Introduction of Good Manufacturing Practice (GMP) and Good
    Clinical Practice (GCP)
  • GMP Controls

ILTP02 – Introduction to Laboratory Testing & GLP

  • Important laboratory techniques
  • Exposure to major pharmaceutical instruments
  • GLP Guidelines

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

  • Pharmaceutical and Biotechnology Formulation and
    Manufacturing Technology
  • Drug Formulation
  • Manufacturing Technologies

ICS002 – Introduction to Clinical Studies

  • Introduction to the concept of Good Clinical Practice in clinical
    research
  • The key elements of the ICH Good Clinical Practices
  • Ethical and scientific quality standards for designing, conducting,
    recording and reporting trials that involve the participation of
    human subjects

STW005 – Scientific-Technical Writing

  • Different types of technical writing in many areas (QA, QC, R&D,
    Manufacturing, Pharmaceutical And Biotechnology Formulation
    And Validation)
  • SOPs, Communication Methods And Issues, Validation Reports
    Writing, Testing Methods, CofAs, CAPA, Change Control, Gap
    Analysis, OOT, OOS, Deviation.
  • Dealing with batch records, auditing reports, investigations and
    real work industrial scenarios.

Semester 2

HPL004 – High-performance Liquid Chromatography (HPLC)

  • HPLC fundamentals and functionality
  • Sample preparations
  • Setting-up system
  • Chemstation software
  • Testing and analyzing data
  • Troubleshooting and investigations

HPD001 – HPLC Method Development & Method Validation

  • HPLC/DAD method development and validation for various drug
    products
  • Writing validation protocols
  • Testing and writing validation reports
  • Troubleshooting and investigations

ETUF05 – Collective Validation

  • Equipment Validation &Thermal Validation
  • Utility Validation, Computer Validation & Facility Validation

CLVM01 – Cleaning & Sterile Validation

  • Current cleaning validation practices
  • Writing Protocols, Reports And Master Validation Plans
  • Regulatory requirements of Cleaning Validation
  • Real Work Industrial Scenarios

IRA001 – Introduction to Regulatory Affairs

  • Introduction on Health Canada
  • Role of regulatory affairs, regulatory terminologies

PRV03 – Process Validation

  • Process Validation Concept
  • Rationale, Writing Protocols, Reports and Master Validation
    Plans
  • Real Work Industrial Scenarios

Semester 3

DIS003 – Dissolution & Dissolution Hands-on Training

  • Dissolution Techniques & Applications, USP apparatus,
    Dissolution Testing

  • Report Writing, Calibration, Troubleshooting and
    Maintenance

  • Out of Specification Investigation

GCT005 – Gas Chromatography (GC)

  • Introduction to Gas Chromatography
  • Sample Preparation Techniques, Sample Testing
  • Data processing, Analysis, Report Preparation
  • GC/FID – IQ / OQ / PQ

GCUV002 – GC Method Development & Method Validation

  • Method Development and Method Validation Using the GC /
    FID
  • Major industrial regulations, in terms of developing and
    validating testing methods
  • Performing method development/validation using GC
  • Writing validation report

PKV04 – Packaging Validation & Packaging Components

  • Packaging validation concept and packaging components
  • Writing protocols, reports and master validation plans

PRA004 – Professional Regulatory Affairs

  • An understanding of trends in the pharmaceutical industry
  • Policymaking and product development
  • Regulatory strategies in developing a product
  • Post-approval management of the product
PHA.BIO.ADIP

Pharmaceutical & Biotechnology Advanced Diploma

Credential Awarded: PG Diploma

Duration: Full-time: 48 weeks / Part-time: 116 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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