| Description |
1 online resource |
| Contents |
Chapter 1: Introduction to biotechnology & quality assurance -- Chapter 2: Introduction to quality principles -- Chapter 3: Quality management systems -- Chapter 4: The food & drug administration -- Chapter 5: good guidance practices (GXPS) -- Chapter 6: The drug approval process -- Chapter 7: The regulation of biologics -- Chapter 8: Medical device & combination products -- Chapter 9: Regulation of food & other products -- Chapter 10: FDA enforcement. |
| Summary |
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. |
| Note |
Description based on online resource. |
| Local Note |
Promoted: Local to Global Cooperative Open Textbook Library |
| Language |
In English. |
| Subject |
Biology -- Textbooks.
|
|
Science -- Textbooks.
|
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Biology. (OCoLC)fst00832383
|
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Science. (OCoLC)fst01108176
|
| Genre/Form |
Textbooks. (OCoLC)fst01423863
|
| Added Author |
Austin Community College (Austin, Tex.), issuing body.
|
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Austin Community College (Austin, Tex.). Biotechnology Program.
|
| Added Title |
Quality assurance and regulatory affairs for the biosciences : BITC1340 course textbook - 2019-20 |
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