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LIFE SCIENCES

LIFE SCIENCES. Pharmaceutical Manufacturing Chemical & Biosciences Technology QA/QC in Pharmaceutical Industry Applied Biology & Chemistry. Organization of Life Sciences. Three Main Areas: R&D – Research and Development Production QA/QC – Quality Assurance / Quality Control.

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LIFE SCIENCES

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

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

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

  17. 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

  18. 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)

  19. 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

  20. 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

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

  22. 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

  23. Tour of Labs

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