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TEACHING STUDENTS BASIC LAB SKILLS FOR A REGULATED ENVIRONMENT

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TEACHING STUDENTS BASIC LAB SKILLS FOR A REGULATED ENVIRONMENT

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TEACHING STUDENTS BASIC LAB SKILLS FOR A REGULATED ENVIRONMENT

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  1. TEACHING STUDENTS BASIC LAB SKILLS FOR A REGULATED ENVIRONMENT BIOMAN 2007 Lisa Seidman Madison Area Technical College Madison, WI

  2. WHY THE BASICS? • Needs of students • Needs of employers

  3. MYTH 1 • Basics means simple, easy, obvious • If this were true, far fewer problems in companies and in research labs

  4. BASIC MEANS: • Vital • Essential • Fundamental • Primary • Staple • Must

  5. MYTH 2 • Most of this does not apply in research labs

  6. MYTH 3 • We all learn the basics in high school, or someone else’s class, or by osmosis

  7. MYTH 4 • Basics are boring

  8. BASICS • What are basics? • Different answers, but some common themes

  9. HOW TO TEACH BASICS? • Consciously • Systematically • model 1: way teach children music • model 2: way grad students are taught • Underlying principles

  10. THIS WORKSHOP • Teaching basics consciously • Systematically • Underlying principles

  11. TOPICS FOR THIS WORKSHOP • Quality • Basic lab task – making a solution • Metrology (unifying principles)

  12. STORY OF FRANCES KELSEY • Case study

  13. KELSEY • Purpose: • introduce GMP • introduce process of developing drug • most important: idea of quality • Bureaucrat – who understood quality

  14. QUALITY: THE BIG (BUT BRIEF) PICTURE

  15. WHAT IS BIOTECHNOLOGY? The biotechnology industry transforms scientific knowledge into useful products

  16. OVERVIEW • Talk about product quality systems • In broad way • Apply ideas to the various work places we talked about

  17. QUALITY SYSTEMS • Broad systems of regulations, standards, or policies that ensure the quality of the final product • GMP/GLP/GCP are examples of quality systems

  18. WHAT IS PRODUCT QUALITY? • What is a “good” product in biotechnology? • That depends… • Consider biotech: • Research labs • Testing labs • Production facilities

  19. QUALITY PRODUCT: RESEARCH LAB • Research lab, knowledge is product: • Knowledge of nature (basic research) • Understanding of technology (applied research, R&D)

  20. QUALITY SYSTEMS IN RESEARCH LABS • Quality system in research • Ensure meaningful data • has been around a long time • It is called:

  21. “DOING GOOD SCIENCE” • Less formalized than other quality systems • No one book spells it out • No laws to obey • But it exists

  22. INFORMAL SYSTEM • Consequences of poor quality product not life-threatening so • Government seldom involved in monitoring research quality • Oversight not generally by outside inspectors or auditors

  23. BUT THERE IS OVERSIGHT • Oversight is by peers • Grant review • Publications • Reputation

  24. Compare and contrast situation in research labs and other work places

  25. PRODUCT QUALITY: TESTING LAB • Testing lab: • Information about samples • Good product = result that can be relied on when making decisions

  26. CONSEQUENCES • A poor quality product can be life-threatening or have serious effects

  27. QUALITY SYSTEMS IN TESTING LABS • Include most of what we call “doing good science” plus • Specific formal requirements • Personnel • Equipment • Training • Facilities • Documentation…

  28. You can find a book that spells it out for: • Clinical labs • Forensic labs • Environmental labs…

  29. ENFORCEMENT: TESTING LABS • Since consequences of poor product can be life-threatening • Is outside oversight • FBI • EPA • Etc.

  30. PRODUCT QUALITY: PRODUCTION FACILITY • Make tangible items • Quality product fulfills intended purpose • Ex.: reagent grade salt vs road salt vs table salt

  31. QUALITY SYSTEMS IN PRODUCTION FACILITIES • Depends on nature of product • Poor product may or may not have life-threatening consequences

  32. SO, FOR EXAMPLE • Products for research use, not generally regulated • Agricultural products are regulated in one way • Pharmaceutical products are regulated in another

  33. VOLUNTARY STANDARDS • Companies that are not regulated may choose to comply with a product quality system for business reasons

  34. ISO 9000 • ISO 9000 • Formal product quality system • Extensive • Exists in a series of books • Companies comply voluntarily to improve the quality of products • …and to make more money

  35. OVERSIGHT: ISO 9000 • Oversight by outside auditors, paid by company

  36. BIOTECH AND MEDICAL PRODUCTS • Many biotech companies that make money make medical/pharmaceutical products • Consequences of poor product can be life-threatening

  37. SO… • These products are highly regulated by the government • But, it wasn’t always this way…

  38. history… • CFR, handout

  39. HOW IS QUALITY BUILT INTO A PRODUCT? • No single answer • Requires: • Skilled personnel • Well-designed and maintained facility • Well-constructed processes • Proper raw materials • Documentation • Change control • Validation

  40. ENFORCEMENT • Compliance is enforced by government • FDA

  41. QUALITY IS BASIC • Details may not be essential right now • Idea of quality is essential

  42. LET’S “GO TO THE LAB”VERY BASIC LAB TASKS 1. Write procedure to make 100 mL of a buffer solution that is: 100 mM Tris, pH 7.5 2% NaCl 10 μg/mL of proteinase K • QC “your solution” by checking its conductivity • Check the pH of a Tris buffer solution

  43. PROCEDURE • For 100 mL of 100 mM Tris solution (FW 121.1) weigh out 1.211 g of Tris base. Dissolve in about 60 mL of water and adjust pH to 7.5. • Add 2g of NaCl • 10 μg/mL of proteinase K X 100 mL = 1000 μg = 1 mg. Weigh and add to Tris. • Dissolve, BTV, check pH

  44. VARIABILITY IN APPROACHES? • Value of SOPs in ensuring consistency • Value of communicating among various lab workers • Documentation

  45. WHAT DO STUDENTS NEED TO KNOW? • Conceptual • Why they are making solution, context • How to interpret recipe • Basic calculations • Instrumentation • How to maintain, use, calibrate balance • How to maintain, use, calibrate pH meter • How to measure volume • How to maintain, use, calibrate conductivity meter • Quality control • How to ensure that solution is what it should be— • How to document work

  46. TEACHING • Concrete skills • calculations • using equipment • etc. • These are activities in the lab manual to systematically build these skills

  47. VARIABILITY • Mike Fino

  48. UNDERLYING PRINCIPLES • Quality ideas (e.g. reducing variability and documentation, following directions—SOPs) • Math calculations/ideas that repeat over and over again • Safety practices • Metrology principles

  49. INTRODUCTION TO METROLOGYLisa SeidmanBioman 2007

  50. DEFINITIONS • Metrology is the study of measurements • Measurements are quantitative observations; numerical descriptions