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Glucose test firm's woes don't keep FDA at bay.(Diabetes ...
Binding: Digital Format: HTML Number Of Pages: 4 Publication Date: 1999-05-01 Release Date: 2005-07-28 [... more]
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`Root cause' analysis seen helpful in meeting FDA CAPA ...
Author: Elisa Ludwig Binding: Digital Format: HTML Number Of Pages: 4 Publication Date: 2002-09-01 Release Date: 2005-07-30 [... more]
$5.95
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OTC maker lacks staff, equipment for assays, and ...
Binding: Digital Format: HTML Number Of Pages: 3 Publication Date: 2002-01-01 Release Date: 2005-07-29 [... more]
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Kiel Labs cited for Part 11 and OOS violations in ...
Author: Joseph Pickett Binding: Digital Format: HTML Number Of Pages: 4 Publication Date: 2005-02-01 Release Date: 2006-07-14 [... more]
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September guidance seen forming basis of any Part 11 ...
Author: Joseph Pickett Binding: Digital Format: HTML Number Of Pages: 4 Publication Date: 2004-06-01 Release Date: 2005-08-01 [... more]
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Holter monitor manufacturer's validation problems ...
Binding: Digital Format: HTML Number Of Pages: 2 Publication Date: 2002-10-01 Release Date: 2005-07-31 [... more]
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Schering's failure to fix six items from Jan. 2001 audit ...
Binding: Digital Format: HTML Number Of Pages: 3 Publication Date: 2002-08-01 Release Date: 2005-07-30 [... more]
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WFI can now be produced by any method other than reverse ...
Author: Elisa Ludwig Binding: Digital Format: HTML Number Of Pages: 2 Publication Date: 2005-02-01 Release Date: 2006-07-14 [... more]
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Software validation guidance gives industry flexibility, ...
Binding: Digital Format: HTML Number Of Pages: 3 Publication Date: 2002-01-28 Release Date: 2005-07-29 [... more]
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Staar Surgical cited for failure to do root cause ...
Binding: Digital Format: HTML Number Of Pages: 2 Publication Date: 2004-01-01 Release Date: 2005-07-31 [... more]
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Undocumented design change of dialysis system violates ...
Author: Wallace Witkowski Binding: Digital Format: HTML Number Of Pages: 2 Publication Date: 2002-08-01 Release Date: 2005-07-30 [... more]
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8-step approach suggested for sponsors to audit CROs. ...
Author: A.E. Sadler Binding: Digital Format: HTML Number Of Pages: 5 Publication Date: 2003-01-01 Release Date: 2005-07-31 [... more]
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