Pharmaceutical and Biotechnology Advanced Diploma
Full-Time & Part-Time


Regulatory affairs clinical science pharmacovigilence clinical trial monitoring audits and inspections ethics & human protection

Pharmaceutical and Biotechnology Advanced Diploma

This comprehensive postgraduate diploma program has been designed to meet the requirement and demands of the industrial standards set by potential employers. It covers a wide range of pharmaceutical and biotechnological skill development in QA, QC, R&D, formulation, technology transfer, validation and regulatory affairs.

Course Highlights:

  • Full-time: 48 weeks Program
  • Part-time: 116 weeks Program
  • Hands-on Training
  • Optional Job Assistance for co-op, internship and full-time opportunities within pharmaceutical and bio-pharmaceutical and related sectors

Program Starts

Fall   |   Spring   |   Summer   |   Winter

Admission Requirements

More than 18 years old, Science or Engineering or Equivalent

Click Here for Domestic Applications and Click Here for International Applications

The program includes the following applications:

Good Manufacturing & Good Clinical Practices

This course introduces the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for pharmaceuticals and bio-pharmaceuticals. It prepares students to establish and document a system of GMP controls required to manufacture drug products in Canada, the United States and other parts of the world.

Introduction to Laboratory Testing & GLP

This course will introduce the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP) for pharmaceuticals and biopharmaceuticals. It will address the most important laboratory techniques. Students will also get exposure and experience with all major pharmaceutical instrument. It focuses on real work industrial scenarios.

Dissolution & Hands on Training

This course will introduce dissolution current testing practices, testing requirements, critical components, sample preparation techniques, media preparation, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

High Performance Liquid Chromatography (HPLC)

This course will introduce HPLC theory, components, testing practices, testing requirements, sample preparation techniques, mobile phase preparation, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

Gas Chromatography (GC)

This course will introduce gas chromatography history, concepts, carrier gas, testing requirements, critical components, sample preparation techniques, sample testing, data analysis, report preparation, limitations, IQ/OQ/PQ, calibration, trouble shooting, maintenance, and out of specification investigation.

HPLC & UV for Dissolution: Method Development & Method Validation
This course will introduce how to initiate and perform method development and method validation using the HPLC /UV and the Dissolution Apparatus. It will cover major industrial regulations in terms of developing and validating testing methods.

GC & UV Spectrometer: Method Development & Method Validation

This course will introduce how to initiate and perform method development and method validation using the GC /UV. It will cover major industrial regulations, in terms of developing and validating testing methods.

Pharmaceutical/ Bio-Pharmaceutical Manufacturing Formulation & Validation Technology

This course will introduce manufacturing technology, all types of validation (process, packaging, cleaning, utility, facility, computer and thermal), drug formulation (solid, liquid, suspension, powder and bio- pharmaceutical process such as fermentation and filtration) and manufacturing technologies (equipment dynamics and etc).

Collective Validation

This course will cover collective validation technology and regulations related to specific validation topics: equipment qualification, thermal validation, utility qualification, computer validation and facility validation.

Cleaning & Sterile Validation

This course will introduce current cleaning validation practices, rationale, worst case scenarios, writing protocols, reports and master validation plans, as well as the regulatory requirements of cleaning validation that lead to risk-based, practical and scientific informed decisions and planned activities. It focuses on real work industrial scenarios.

Packaging Validation & Packaging Components

This course will cover packaging validation concept and packaging components, writing protocols, reports and master validation plans, as well as the regulatory requirements of packaging validation that lead to risk- based, reasonable and scientific informed decisions and planned activities. It focuses on real work industrial scenarios.

Process Validation

This course will cover process validation concept, rationale, writing protocols, reports and master validation plans, as well as the regulatory requirements of process validation that lead to risk-based, practical and scientific informed decisions and planned activities. It focuses on real work industrial scenarios.

Introduction to Regulatory Affairs

Pharmaceutical Modern Technology course will introduce Introduction on Health Canada, role of regulatory affairs, regulatory terminologies – DIN, NDS, ANDS,OTC & CTC ,drug discovery timeline, phases of clinical trials, ICH-GCP guidelines and common technical document, NDA / NDS submission, ANDA / ANDS submission, DIN# and NPN#, quality assurance and regulatory affairs and post approval activities.

Professional Regulatory Affairs

Pharmaceutical Modern Technology course builds upon the clinical regulatory foundation built in IRA001. It provides students with an understanding of the trends in pharmaceutical industry, with regards to policy making and product development. The topics also include regulatory strategies in developing a product and post approval management of the product.

Introduction to Clinical Studies

This course is aimed to introduce the concept of Good Clinical Practice in clinical research. The key elements of the ICH Good Clinical Practices will be discussed, including the ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Scientific Technical Writing

This course will introduce different types of technical writing in many areas (QA, QC, R&D, Manufacturing, Formulation and Validation) and compiling scientific documents: SOPs, communication methods and issues, validation reports writing, validation protocols writing, dealing with batch records, auditing reports, investigations and real work industrial scenarios.

PROGRAM HIGHLIGHTS:

  • Good Manufacturing & Good Clinical Practices
  • Introduction to Laboratory Testing & GLP
  • Dissolution & Hands-on Training
  • High-Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • HPLC & UV for Dissolution: Method Development & Method Validation
  • GC & UV Spectrometer: Method Development & Method Validation
  • Pharmaceutical and Biotechnology Formulation & Validation Technology
  • Collective Validation
  • Cleaning & Sterile Validation
  • Packaging Validation & Packaging Components
  • Process Validation
  • Introduction to Regulatory Affairs
  • Professional Regulatory Affairs
  • Introduction to Clinical Studies
  • Scientific Technical Writing

Job Opportunities in Multiple Departments:

Quality Control and Quality Assurance Area:

Technologists, Raw Material Chemists, Finish Product Chemists, Stability Chemists, R&D Chemists, Scientists, Calibration Chemists, Document Reviewers, Laboratory Coordinators, Trainers, SOP Writers, Auditors, Supervisors, and Managers.


Formulation Area:

Laboratory Coordinators, Formulation Technicians, Production Operators, Formulation Scientists and Formulation Managers/Directors.


Technology Transfer Area:

Validation Assistants, Process Development Scientists, Technology Transfer Specialists, Technology Transfer Coordinators and Document Coordinators.


Validation Area:

Process Validation Scientists, IQ/OQ/PQ Specialists, Cleaning Validation Specialists, Packaging Validation Specialists, Thermal Validation Specialists, Computer Validation Specialists and Validation Managers.


Regulatory Affairs Area:

Regulatory Affairs Associates, Reviewers, Auditors, and Managers/Supervisors/Directors.


Clinical Research Area:

Clinical Research Scientists, Clinical Research Organizers /Associates, Managers/ Supervisors/Directors. Regulatory Affairs Area: Regulatory Affairs Associates, Auditors, and Regulatory Affairs Managers/Supervisors/Directors.

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