Industrial Pharmaceutical & Bio-Pharmaceutical Manufacturing Formulation and Validation Technology

This diploma program has been designed to meet the skill requirements for effectively performing duties in Manufacturing Formulation and Validation Technology areas in Pharmaceutical and Bio-Pharmaceutical industries for those who want to upgrade existing skills or obtain new skills. Each area of the study will be covered in an in-depth manner for both Pharmaceutical and Bio- Pharmaceutical sectors.

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Program Starts: Fall, Spring, Summer & Winter

Admission Requirements: Minimum of Grade 12 Diploma with required science and math courses.

The program includes the following applications:

This course will introduce the concepts and requirements necessary for compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for pharmaceuticals and biopharmaceuticals. It will prepare students to establish and document a system of GMP controls required to manufacture drug products in Canada, the United States and in many parts of the world. It focuses on real work industrial scenarios.

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).

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

This course will cover the objectives of formulation, pre-formulation techniques, manufacturing formulation techniques, and related regulations.

This course will cover the formulation mechanism for solid dosages, liquid, suspension, power, fermentation, filtration, media preparation and etc, along with process analytical techniques and solid dosage evaluation.

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.

This course will introduce assessment of complex cleaning validation processes, how to develop process of new equipment/product, worst case selection process, and risk base analysis for technical overview. It focuses on real work industrial scenarios.

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.

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.

This course will cover both complex processes and packaging validation techniques. It will also cover the risk based analysis, technology transfer, feasibility studies and etc.

This course will introduce different types of writing 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.

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).

 

Course Highlights:

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

Job Opportunities in Multiple Departments:

Formulation Area: Formulation Chemists, Formulation Technicians, Production Operators, Formulation Scientists and Formulation Managers /Directors.

Technology Transfer Area: Process Development Scientists, Technology Transfer Coordinators, and Document Coordinators.

Validation Area: Validation Assistants, Process Validation Scientists, Technology Transfer Scientists, IQ/OQ/PQ Specialists, Cleaning Validation Specialists, Packaging Validation Specialists, Thermal Validation Specialists, Computer Validation Specialists and Validation Managers.