000 03150nam a22004215i 4500
001 978-1-4614-7642-9
003 DE-He213
005 20140220082830.0
007 cr nn 008mamaa
008 130622s2013 xxu| s |||| 0|eng d
020 _a9781461476429
_9978-1-4614-7642-9
024 7 _a10.1007/978-1-4614-7642-9
_2doi
050 4 _aRS380
050 4 _aRS190-210
072 7 _aTDCW
_2bicssc
072 7 _aMED072000
_2bisacsh
082 0 4 _a615.19
_223
100 1 _aCatalano, Thomas.
_eauthor.
245 1 0 _aEssential Elements for a GMP Analytical Chemistry Department
_h[electronic resource] /
_cby Thomas Catalano.
264 1 _aNew York, NY :
_bSpringer New York :
_bImprint: Springer,
_c2013.
300 _aXIV, 195 p. 54 illus., 19 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aIntroduction -- Organization -- Department Structure -- Project Teams -- Responsibilities -- Interactions -- Operating Guidance’s -- Processes -- Safety -- Technology -- Department -- Statistical Concepts for the Analytical Chemist -- Data distribution -- Significance Testing -- Confidence Intervals -- Outliers in analytical data -- Regression -- Experimental design -- Required sample replicates -- Method performance -- Uncertainty measurement -- Sampling strategies -- Outsourcing -- Process -- Audit Check List -- Documentation -- Sample Submission -- Technical Report -- Reports of analysis -- Records (Training etc.) -- Job Descriptions -- Career Tracks -- Motivating Personnel -- Career Path -- Hiring the Best.
520 _aEssential Elements for a GMP Analytical Chemistry Department identifies the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction, thereby encouraging the sharing of ideas, skills, and abilities among department personnel.  The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, statistical concepts, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. Essential Elements for a GMP Analytical Chemistry Department can be an asset to many companies required to perform GMP analytical method development, validation, analyses, documentation, etc…
650 0 _aMedicine.
650 0 _aPharmaceutical technology.
650 1 4 _aBiomedicine.
650 2 4 _aPharmaceutical Sciences/Technology.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781461476412
856 4 0 _uhttp://dx.doi.org/10.1007/978-1-4614-7642-9
912 _aZDB-2-SBL
999 _c95953
_d95953