Industrial Pharmaceutical & Bio-Pharmaceutical Modern Technology Full-time/Part-time

Industrial Pharmaceutical & Bio-Pharmaceutical Modern Technology Full-time/Part-time

This comprehensive postgraduate diploma program has been developed to meet the skill requirements for effectively performing duties in the entire field of pharmaceutical/bio-pharmaceutical industries for those who want to upgrade existing skills or obtain new skills. Each area of study will be covered in-depth for both pharmaceutical and bio-pharmaceutical sectors.

Industrial Pharmaceutical & Bio-Pharmaceutical Modern Technology Full-time/Part-time

Admission Requirement

Science/Engineering/Technology Degree or Diploma/Equivalent.

Duration: 10 Months

Hands-on Training along with Job Assistance: The program includes 10 months hands-on training, 4 months of Job Assistance for qualified students along with resume preparation and learning interview tactics and tips.

Areas of Study

Good Manufacturing & Good Clinical Practices, Course Code: GCCP01

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.

The graduates will be able to demonstrate a good understanding of both GMP and GCP guidelines, the functional aspects of each guideline, responding to citations for audit agencies, corrective preventive action plans, change controls, and health risk classifications. It focuses on real work industrial scenarios.

 

Introduction to Laboratory Testing & GLP, Course Code:ILTP02

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.

The graduates will have a good understanding of the GLP guidelines widely used in pharmaceutical and related sectors, the functional aspects of these guidelines in various processes and procedures, as well as a good understanding of instrumentations, calibration and the application of various instruments.

Dissolution & Dissolution Hands-on Training, Course Code:DIS003

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.

The graduates will have a good understanding of dissolution techniques, applications, USP apparatus, dissolution testing, report writing, calibration, trouble shooting, maintenance and out of specification investigation. It focuses on real work industrial scenarios.

High performance Liquid Chromatography (HPLC), Course Code:HPL004

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.

The graduates will have a good understanding of HPLC techniques, applications, Chemstation software, HPLC testing (identification, assay, content uniformity and etc.), report writing, calibration, trouble shooting, maintenance, and out of specification investigation. It focuses on real work industrial scenarios.

Gas Chromatography (GC), Course Code:GCT005

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.

The graduates will have a good understanding of GC techniques, applications, Chemstation software, head space, GC testing (identification, assay, content uniformity and etc), report writing, calibration, trouble shooting, maintenance, and out of specification investigation. It focuses on real work industrial scenarios.

Areas of Study

HPLC & UV for Dissolution: Method Development & Method

Validation, Course Code:HPD001

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.

The graduates will have a good understanding of HPLC method development and method validation for various pharmaceutical products, the application of Chemstation, validation guidelines, report writing and trouble shooting. It focuses on real work industrial scenarios

GC & UV Spectrometer: Method Development & Method Validation, Course Code:GCUV002

This course willintroduce 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.

The graduates will have a good understanding of GC method development and method validation for various pharmaceutical products, the application of headspace, validation guidelines, report writing and trouble shooting. It focuses on real work industrial scenarios.

Pharmaceutical/Bio-Pharmaceutical Manufacturing Formulation & Validation Technology, Course Code:PMVT01

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).

Students will know the fundamental of drug formulation for solid, liquid, suspension, powder and bio- pharmaceutical process such as fermentation and filtration and manufacturing technology (equipment dynamics and etc). They will also get introduced to various validation technology, fundamentals and guidelines.

Collective Validation, Course Code:ETUF05
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.

Students will get to know how to initiate and conduct equipment, thermal, utility, computer and facility validation studies. They will also learn the related regulations and report writing for those studies.

Cleaning & Sterile Validation, Course Code:CLVM01

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.

Students will know how to initiate and conduct cleaning validation studies. They will also learn the related current cleaning validation regulations and report writing for those validation studies.

Packaging Validation & Packaging Components, Course Code:PKV04

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.

Students will get to know how to initiate and conduct packaging validation studies. They will also learn the related current packaging validation regulations and report writing for those validation studies.

Process Validation, Course Code:PRV03

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.

Students will know how to initiate and conduct process validation studies in pharmaceutical and bio- pharmaceutical industries. They will also learn the related current process validation regulations and report writing for those validation studies.

Introduction to Regulatory Affairs, Course Code:IRA001

This 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.

The graduates of this course will have a good understanding of the laws and regulations governing regulatory process. At the end of the course, they will be able to complete the required regulatory documents (i.e. CTA, IND) for the regulatory agency, in order to obtain approval from the government for conducting further studies.

Professional Regulatory Affairs, Course Code:PRA004

This 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.

The graduates of this course will have a good understanding of regulatory strategies in developing a product and post approval management of the product, along with PMS and related regulations.

Areas of Study

Introduction to Clinical Studies, Course Code:ICS002

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.

The graduates will be able to demonstrate a good understanding of the ethical principles related to clinical trial, understand the meaning of “protection of the rights, well-being and safety of the trial subjects”, be able to list all the essential documents required to collectively permit evaluation throughout the conduct of a trial and the quality of the data produced, and be able to understand the roles and responsibilities of an investigator, a sponsor, a Clinical Research Organization, the Research Ethics Board and the subjects in a clinical trial.

Scientific Technical Writing, Course Code:STW005

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.

The graduates will be able to initiate and write various SOPs, protocols, study reports, OOS and deviation reports, batch records, change controls, and CAPAs. They will also learn the functionality of each department and the documentation aspect of each function.

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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