LIFE SCIENCES

Pharmaceutical ManufacturingChemical & Biosciences TechnologyQA/QC in Pharmaceutical IndustryApplied Biology & Chemistry

Organization of Life Sciences

Three Main Areas:

R&D – Research and Development

Production QA/QC – Quality

Assurance / Quality Control

Responsibilities in Research

Find product with commercial value

Characterize – (composition, potency, shelf-life)

Establish product specifications Develop testing methods Develop manufacture process Microbiological considerations Raw materials specifications Equipment required

Research Job Titles

Scientist Research scientist Research Associate Research Technician Laboratory Technician Laboratory Scientist Media Preparation Technician

Responsibilities of Production Team

Make the product – biochemical, etc.

Work with large volumes / equipment

Routine monitoring and control Routine cleaning, calibration and

maintenance of equipment Following SOP (standard operating

procedures) Initiating corrective procedures Completing forms, labels, log-

books

Production Job Titles

Manufacturing Operator Manufacturing Technician Manufacturing Supervisor Production Technician Pilot Plant Operator Pilot Plant Technician

Responsibilities of QA / QC Team

Monitor equipment, facilities, personnel, product

Review all production procedures Ensures document accuracy Test samples of product and raw

materials Compare to established

standards Approve product release Review customer complaints

QC / QA Job Titles

Quality Assurance Technician

Quality Control Technician

Assay Analyst Documentation

Specialist Compliance

Specialist Internal Auditor

Different Types of Work Environments

Academic / Gov. Research

investigate fundamental problems in biology / chemistry (etc.)

Product is knowledge or information

May eventually be applied to a commercial product

Different Types of Work Environments

R&D Laboratories in Industry

Investigate areas with intent of a commercial product

Focused, aggressive, highly effective

Different Types of Work Environments

Production Facilities Produce products to exact

specifications Often uses large-scale

equipment Can be simple or highly

complex Often a large-scale

version of bench-scale research

Different Types of Work Environments

Testing Labs (QA, Microbiol, Clinical)

Perform tests on samples / devices

May be highly routine May be highly variable Nature of work varies

with specific area

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing

High school graduation with Chemistry 40S 2 academic terms & Co-op Production/Manufacturing Solid Dose Biopharmaceutical Certificate

Pharmaceutical ManufacturingTerm 1 Courses

Intro to Pharmaceutics Intro to Chemistry of Drug Compds Technical Math Microbiology Quality & Compliance Solid Dosage 1(granulation) Solid Dosage 2(tableting, coating)

Term 2 Courses

Technical Writing Workplace Safety Intro to Liquid & Semi-solid dosage Applied Biopharmaceutics

(fermentation) Applied Biopharmaceutics

(separation) Pharmaceutical project

Chemical & Biosciences

PROGRAM OVERVIEW

Chemistry – Organic, Biochemistry Biology- Microbiology, Molecular

biology, immunology, tissue culture, nutraceuticals, etc.

Instrumentation – Chromatography, HPLC, GC, Applied instrumentation

Mathematics – Statistics, data analysis Related courses – communications,

safety, etc. 4 academic terms & 2 co-op terms

QA/QC in Pharmaceutical Industry

Graduation from a science related diploma or degree program with courses in chemistry and microbiology or equivalent

GMP regulated labs/companies GLP regulated labs 1 year post-graduate diploma

program (with Co-op)

Main QA/QC courses

QA for Pharmaceutical Industry Quality Control Analysis 1 & 2 Analytical Instrumentation 1 & 2 Intro to Pharmaceutical Industry Writing for Life Sciences Workplace Safety

Applied Biology & Applied Chemistry

Joint Program with U of Winnipeg Register & start at U of W 2-1-1 program Year 3 at RRC Graduates receive Degree &

Diploma

“Essential Skills” Checklists

Primary, Secondary and Specific Skills

Students acquire applied skills

Instructors focus on needed areas

Employers identify desired elements

Secondary Skills

Interaction / Professional Communications Adherence to Safety Protocols Pre-activity Preparation Post-activity follow-up Comprehension of Principles / Theory Professional Enthusiasm Sanitation / Post-Laboratory Clean-up Acquisition of Group / Team Data Standardization / Calibration Activities Maintain Focus During Routine Activities

Tour of Labs