000 01837nam a2200373 4500
001 OTLid0000911
003 MnU
005 20201105133416.0
006 m o d s
008 200908s2019 mnu o 0 0 eng d
020 _a
040 _aMnU
_beng
_cMnU
050 4 _aQH308.2
050 4 _aQH301
245 0 0 _aQuality Assurance & Regulatory Affairs for the Biosciences
_cJack O'Grady
264 2 _bOpen Textbook Library
264 1 _bAustin Community College
300 _a1 online resource
490 0 _aOpen textbook library.
505 0 _aCHAPTER 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
520 0 _aThis 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.
542 1 _fAttribution
546 _aIn English.
588 0 _aDescription based on online resource
650 0 _aBiology
_vTextbooks
650 0 _aScience
_vTextbooks
700 1 _aO'Grady, Jack
_eauthor
710 2 _aOpen Textbook Library
_edistributor
856 4 0 _uhttps://open.umn.edu/opentextbooks/textbooks/911
_zAccess online version
999 _c20245
_d20245