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Welcome from the Co-Chairs (pdf)
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Piet Christiaens, PhD & Kevin Constable (pdf)
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End User Testing for Performance Qualification of GXP Part 11 Systems - Off the Shelf - OTS - Teri Stokes PhD (pdf)
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Registration Form (pdf)
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PDA FDA meeting PAC Washington PA Ruffieux (pdf)
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Examples of GMP Deficiencies Issued by HPRA in relation to CMOs, Contract Labs (pdf)
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Opening Session_Roberto Conocchia (pdf)
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EMA Draft Guidance on Good Distribution Practice of Medicinal Products for Human Use 31 Dec 2011 (pdf)
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