000			01553nam a2200157Ia 4500
008			140223b2011 xxu||||| |||| 00| 0 eng d
020			_a9780470476598 _c0.00
082			_a610.28 _bZHO
100			_aZhou, Michael _9110611
245			_aRegulated Bioanalytical Laboratories: technical and regulatory aspects from global perspectives
260			_aHoboken, New Jersey _bWiley _c2011
300			_a526p
500			_aThis book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
942			_2ddc _cLB
995			_aPharmacy Reference _eP0008081 _j610.28 _yP0008081
999			_c16234 _d16234