1. LIFE SCIENCES Pharmaceutical Manufacturing Chemical & Biosciences Technology QA/QC in Pharmaceutical Industry Applied Biology & Chemistry

2. Organization of Life Sciences Three Main Areas:  R&D – Research and Development  Production  QA/QC – Quality Assurance / Quality Control

3. 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

4. Research Job Titles  Scientist  Research scientist  Research Associate  Research Technician  Laboratory Technician  Laboratory Scientist  Media Preparation Technician

5. 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

6. Production Job Titles  Manufacturing Operator  Manufacturing Technician  Manufacturing Supervisor  Production Technician  Pilot Plant Operator  Pilot Plant Technician

7. 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

8. QC / QA Job Titles  Quality Assurance Technician  Quality Control Technician  Assay Analyst  Documentation Specialist  Compliance Specialist  Internal Auditor

9. 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

10. Different Types of Work Environments R&D Laboratories in Industry  Investigate areas with intent of a commercial product  Focused, aggressive, highly effective

11. 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

12. 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

13. Pharmaceutical Manufacturing

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

15. Pharmaceutical Manufacturing Term 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)

17. Term 2 Courses  Technical Writing  Workplace Safety  Intro to Liquid & Semi-solid dosage  Applied Biopharmaceutics (fermentation)  Applied Biopharmaceutics (separation)  Pharmaceutical project

19. 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

20. 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)

21. 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

22. 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

23. “Essential Skills” Checklists  Primary, Secondary and Specific Skills  Students acquire applied skills  Instructors focus on needed areas  Employers identify desired elements

24. 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

25. Tour of Labs