%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R ] /Count 1 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 24 0 R /I4 25 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220609135740-04'00') /ModDate (D:20220609135740-04'00') /Title (Managing Knowledge and Risk A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 18 0 R 20 0 R 22 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 2389 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(Managing Knowledge and Risk A Literature Review on the Interdependency of )] TJ ET BT 45.016 644.329 Td /F3 15.0 Tf [(QRM and KM as ICH Q10 Enablers)] TJ ET q 45.016 592.470 506.159 33.750 re W n 0.800 0.800 0.800 rg 45.016 625.845 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 605.856 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 625.845 216.702 0.750 re f 0.000 0.000 0.000 rg BT 58.021 607.731 Td /F4 9.0 Tf [(Martin J. Lipa, Kevin O'Donnell, and Anne Greene)] TJ ET 0.800 0.800 0.800 rg 274.723 625.845 110.556 0.750 re f 0.000 0.000 0.000 rg BT 274.723 607.731 Td /F4 9.0 Tf [(Sep 24, 2020 7:00 am EDT)] TJ ET Q BT 45.016 489.981 Td /F1 9.0 Tf [(INTRODUCTION In 2010, when ICH published Q10 Pharmaceutical Quality System [1], Quality Risk Management \(QRM\) )] TJ ET BT 531.664 489.981 Td /F1 9.0 Tf [(and )] TJ ET BT 45.016 476.245 Td /F1 9.0 Tf [(Knowledge Management \(KM\) were clearly identified as key enablers to supporting an effective Pharmaceutical Quality )] TJ ET BT 45.016 462.509 Td /F1 9.0 Tf [(System \(PQS\). While the authors of ICH Q10 recognized the role, both play in ensuring)] TJ ET q 45.016 448.512 506.159 0.000 re W n Q 0.620 0.620 0.620 rg 45.016 407.262 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 389.736 Td /F4 10.7 Tf [(Source URL:)] TJ ET BT 112.587 389.736 Td /F1 10.7 Tf [(http://www.ivtnetwork.com/article/managing-knowledge-and-risk-%E2%80%93-literature-)] TJ ET 0.000 0.000 0.000 RG 0.21336 w 0 J [ ] 0 d 112.587 388.372 m 531.125 388.372 l S BT 45.016 373.454 Td /F1 10.7 Tf [(review-interdependency-qrm-and-km-ich-q10-enabler-0)] TJ ET 0.21336 w 0 J [ ] 0 d 45.016 372.090 m 306.446 372.090 l S 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 509.220 147.750 75.000 re S q 146.250 0 0 73.500 65.266 509.970 cm /I4 Do Q endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
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