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Biogen specific teaching material presentation - Please read it first before starting to learn

Quizlet Link-List (Lessons 1-47) French & German

1. Basic Principles of Safety – Air classification Particulates

2. Basic Principles of Process Control Systems and Automation – Automation systems

3. Measurement of Variables Critical to Controlling Processes – Conductivity

4. Basic Principles of Process Control Systems and Automation – Measurement of Variables Critical to Controlling Processes – pH

5. Basic Principles of Process Control Systems and Automation – Measurement of Variables Critical to Controlling Processes – Temperature

6. Basic Principles of Process Control Systems and Automation – Measurement of Variables Critical to Controlling Processes

7. Basic Principles of Process Control Systems and Automation – Recipe-driven Operations

8. Basic Principles of Process Control Systems and Automation – Types of Analytical Methods, Cell Counting

9. Buffer and Media Preparation – How to Prepare a Solution

10. Buffer and Media Preparation – Types of Water

11. Buffer and Media Preparation – What is a Buffer?

12. CFR – Code of Federal Regulations

13. Cleaning and Disinfection – Importance of Cleaning and Disinfection in Aseptic Processing Areas

14. Cleaning and Disinfection – Basic Microbiology

15. Cleaning and Disinfection – Cleaning

16. Cleaning and Disinfection – Disinfection

17. Cleaning and Disinfection – Environmental Monitoring

18. Cleaning and Disinfection – Regulatory Requirements

19. EMA – European Medicines Agency

20. FDA – Food and Drug Administration

21. Good Manufacturing Practice Regulations

22. ICH – International Council for Harmonisation

23. Introduction to DSP – Cell Separation

24. Introduction to DSP – Chromatography

25. Introduction to DSP – Harvesting

26. Introduction to DSP – Proteins and Their Structure

27. Introduction to USP – Critical Biotech Parameters

28. Introduction to USP – Fed-Batch Operation

29. Introduction to USP – Seed Train Development

30. Introduction to USP – What is a Bioreactor?

31. Quality – Data Integrity

32. Quality – Compliance

33. Quality – GDP (Good Documentation Practice) Rules

34. Quality – Importance of Making Quality Products

35. Basic Principles of Safety – Workplace Safety Attitudes

36. Basic Principles of Safety – Chemicals – (Material) Safety Data Sheet, or (M)SDS

37. Basic Principles of Safety – Pressure

38. Basic Principles of Safety – Chemicals – Splashes

39. Basic Principles of Safety – Chemicals – Steam

40. Basic Principles of Safety – Classification Levels Within an Aseptic Facility

41. Basic Principles of Safety – Design Criteria

42. Basic Principles of Safety – Gowning

43. Basic Principles of Safety – HVAC

44. Basic Principles of Safety – Hygiene

45. Basic Principles of Safety – LOTO During Repair & Maintenance

46. Basic Principles of Safety – Plant Design

47. Swissmedic – Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products)