Quality Assurance and Regulatory Affairs for the Biosciences

by Jack O'Grady

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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.

Description from LibreTexts.

Publisher
Austin Community College
Subjects
Biology, Biotechnology
Licence
CC BY, as LibreTexts states it
Who can read
Tweens profiles and older, judged from its title and subjects

Contents

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  1. Front Matter
  2. TitlePage
  3. InfoPage
  4. Table of Contents
  5. Licensing
  6. 1: Introduction to Biotechnology and Quality Assurance
  7. 1.1: Introduction to Biotechnology
  8. 1.2: Modern Applications to Biotechnology
  9. 1.3: The Structure of a Biotechnology Company
  10. 1.4: How is Quality Involved Company-Wide?
  11. 1.5: An Introduction to Quality
  12. 1.6: Quality Principles
  13. 1.7: Quality Systems and Approaches
  14. 1.8: Quality (Professional) Organizations
  15. 2: Introduction to Quality Principles
  16. 2.1: History of Quality
  17. 2.2: Quality Pioneers
  18. 2.3: The Juran Trilogy
  19. 2.4: Feigenbaum - Total Quality Management (TQM)
  20. 2.5: Company Culture and Employee Needs
  21. 2.6: Establishing Quality Control - The Essentials
  22. 2.7: Inspection, Audit, and Surveillance
  23. 2.8: Validation of Processes and Equipment
  24. 2.9: Nonconformance
  25. 3: Quality Management Systems
  26. 3.1: Quality Systems in the Workplace and in Research Labs
  27. 3.2: Quality Systems in Companies
  28. 3.3: ISO
  29. 3.4: Other Voluntary Quality Mangement Systems
  30. 3.5: Lean Manufacturing
  31. 4: The Food and Drug Administration
  32. 4.1: Consumer Safety and Health
  33. 4.2: The Food and Drug Administration (FDA)
  34. 4.3: The Code of Federal Regulations (CFR)
  35. 5: Good Guidance Practices (GXPs)
  36. 5.1: Good Laboratory Practices (GLPs)
  37. 5.2: Good Clinical Practices (GCP)
  38. 5.3: Current Good Manufacturing Practices (CGMPs)
  39. 5.4: Good Documentation Practices (GDPs)
  40. 6: The Drug Approval Process
  41. 6.1: Introduction – The Pharmaceutical Product Approval Process
  42. 6.2: The Drug Development Process
  43. 6.3: Different Drug Application Review Processes
  44. 6.4: Post-Marketing
  45. 7: The Regulation of Biologics
  46. 7.1: Introduction to Biologics
  47. 7.2: The Center for Biologics, Evaluation, and Research
  48. 7.3: Processes for Drug Approval
  49. 7.4: Office of Compliance & Biologics Quality (OCBQ)
  50. 7.5: Labeling
  51. 8: Medical Device and Combination Products
  52. 8.1: Introduction to Medical Devices and Classifications
  53. 8.2: Market Submission Options
  54. 8.3: Regulation of Clinical Tests
  55. 8.4: More Regulations
  56. 8.5: Combination Products
  57. 8.6: Determining Regulatory Pathways
  58. 9: Regulation of Food and Other Products
  59. 9.1: Food Safety
  60. 9.2: Regulation of Plant GMOs
  61. 9.3: Regulation of Animal GMOs and Medical Foods
  62. 9.4: Regulation of Veterinary Products
  63. 9.5: Regulation of Cosmetics
  64. 10: FDA Enforcement
  65. 10.1: FDA Monitoring and Enforcement
  66. 10.2: Enforcement Terminologies
  67. 10.3: Enforcement Activities
  68. 10.4: Recalls
  69. Back Matter
  70. Index
  71. Works Cited
  72. Detailed Licensing