Nguồn ngoài
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.
- Tác giả
- Jack O'Grady
- Nhà xuất bản
- Austin Community College
- Nguồn
- LibreTexts
- Giấy phép
- CC BY
- Ngôn ngữ
- EN
- Danh mục
- Khoa học cơ bản
Mục lục· 63 mục
- 01: Introduction to Biotechnology and Quality Assurance
- 1.01: Introduction to Biotechnology
- 1.02: Modern Applications to Biotechnology
- 1.03: The Structure of a Biotechnology Company
- 1.04: How is Quality Involved Company-Wide
- 1.05: An Introduction to Quality
- 1.06: Quality Principles
- 1.07: Quality Systems and Approaches
- 1.08: Quality (Professional) Organizations
- 02: Introduction to Quality Principles
- 2.01: History of Quality
- 2.02: Quality Pioneers
- 2.03: Section 3-
- 2.04: Section 4-
- 2.05: Section 5-
- 2.06: Section 6-
- 2.7: Inspection Audit and Surveillance
- 2.8: Validation of Processes and Equipment
- 2.9: Nonconformance
- 03: Quality Management Systems
- 3.01: Section 1-
- 3.02: Section 2-
- 3.03: Section 3-
- 3.04: Section 4-
- 3.05: Section 5-
- 04: The Food and Drug Administration
- 4.01: Section 1-
- 4.02: Section 2-
- 4.03: Section 3-
- 05: Good Guidance Practices (GXPs)
- 5.01: Section 1-
- 5.02: Section 2-
- 5.03: Section 3-
- 5.04: Section 4-
- 06: The Drug Approval Process
- 6.01: Section 1-
- 6.02: Section 2-
- 6.4: Post-Marketing
- 6.04: Section 4-
- 07: The Regulation of Biologics
- 7.01: Section 1-
- 7.02: Section 2-
- 7.03: Section 3-
- 7.04: Section 4-
- 7.05: Section 5-
- 08: Medical Device and Combination Products
- 8.01: Section 1-
- 8.02: Section 2-
- 8.03: Section 3-
- 8.04: Section 4-
- 8.05: Section 5-
- 8.06: Section 6-
- 09: Regulation of Food and Other Products
- 9.01: Section 1-
- 9.02: Section 2-
- 9.03: Section 3-
- 9.04: Section 4-
- 9.05: Section 5-
- 10: FDA Enforcement
- 10.01: Section 1-
- 10.02: Section 2-
- 10.03: Section 3-
- 10.04: Section 4-