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Quality Assurance and Regulatory Affairs for the Biosciences

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Quality Assurance and Regulatory Affairs for the Biosciences

This 125-page course textbook, entitled Quality Assurance & Regulatory Affairs for the Biosciences, was created by Jack O'Grady, M.S., professor at Austin Community College. This textbook accompanies the course BITC 1340: Quality Assurance for the Biosciences.

BiotechnologyBiology
Author
Jack O'Grady
Publisher
Austin Community College
Source
LibreTexts
License
CC BY
Language
EN
Category
Basic Sciences
Read online Download PDF (open licence)
Contents· 63 sections
  1. 01: Introduction to Biotechnology and Quality Assurance
  2. 1.01: Introduction to Biotechnology
  3. 1.02: Modern Applications to Biotechnology
  4. 1.03: The Structure of a Biotechnology Company
  5. 1.04: How is Quality Involved Company-Wide
  6. 1.05: An Introduction to Quality
  7. 1.06: Quality Principles
  8. 1.07: Quality Systems and Approaches
  9. 1.08: Quality (Professional) Organizations
  10. 02: Introduction to Quality Principles
  11. 2.01: History of Quality
  12. 2.02: Quality Pioneers
  13. 2.03: Section 3-
  14. 2.04: Section 4-
  15. 2.05: Section 5-
  16. 2.06: Section 6-
  17. 2.7: Inspection Audit and Surveillance
  18. 2.8: Validation of Processes and Equipment
  19. 2.9: Nonconformance
  20. 03: Quality Management Systems
  21. 3.01: Section 1-
  22. 3.02: Section 2-
  23. 3.03: Section 3-
  24. 3.04: Section 4-
  25. 3.05: Section 5-
  26. 04: The Food and Drug Administration
  27. 4.01: Section 1-
  28. 4.02: Section 2-
  29. 4.03: Section 3-
  30. 05: Good Guidance Practices (GXPs)
  31. 5.01: Section 1-
  32. 5.02: Section 2-
  33. 5.03: Section 3-
  34. 5.04: Section 4-
  35. 06: The Drug Approval Process
  36. 6.01: Section 1-
  37. 6.02: Section 2-
  38. 6.4: Post-Marketing
  39. 6.04: Section 4-
  40. 07: The Regulation of Biologics
  41. 7.01: Section 1-
  42. 7.02: Section 2-
  43. 7.03: Section 3-
  44. 7.04: Section 4-
  45. 7.05: Section 5-
  46. 08: Medical Device and Combination Products
  47. 8.01: Section 1-
  48. 8.02: Section 2-
  49. 8.03: Section 3-
  50. 8.04: Section 4-
  51. 8.05: Section 5-
  52. 8.06: Section 6-
  53. 09: Regulation of Food and Other Products
  54. 9.01: Section 1-
  55. 9.02: Section 2-
  56. 9.03: Section 3-
  57. 9.04: Section 4-
  58. 9.05: Section 5-
  59. 10: FDA Enforcement
  60. 10.01: Section 1-
  61. 10.02: Section 2-
  62. 10.03: Section 3-
  63. 10.04: Section 4-