%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 31 0 R 33 0 R ] /Count 3 /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 18 0 R /I4 25 0 R /I5 30 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:20220608135309-04'00') /ModDate (D:20220608135309-04'00') /Title (Regulatory 101: Safety Of Titanium Dioxide) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 19 0 R 21 0 R 23 0 R 26 0 R 28 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 4992 >> 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 [(Regulatory 101: Safety Of Titanium Dioxide)] TJ ET q 45.016 555.061 506.159 88.973 re W n 0.800 0.800 0.800 rg 45.016 643.658 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 595.426 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 643.658 68.517 0.750 re f q 31.500 0 0 31.500 61.771 612.533 cm /I3 Do Q 0.000 0.000 0.000 rg BT 126.538 633.044 Td /F4 9.0 Tf [(Karen R. Zimm)] TJ ET BT 126.538 594.044 Td /F1 9.0 Tf [(, )] TJ ET 0.800 0.800 0.800 rg 126.538 643.658 66.528 0.750 re f q 27.000 0 0 31.500 130.288 600.040 cm /I4 Do Q 0.000 0.000 0.000 rg BT 193.066 620.551 Td /F4 9.0 Tf [(Renee Phillips)] TJ ET 0.800 0.800 0.800 rg 193.066 643.658 109.062 0.750 re f 0.000 0.000 0.000 rg BT 193.066 597.301 Td /F4 9.0 Tf [(Jan 20, 2022 8:00 am EST)] TJ ET Q 0.75 w 0 J [ ] 0 d 45.391 79.988 505.409 347.947 re S BT 54.766 407.572 Td 0.653 Tw /F1 9.0 Tf [(Regulatory 101 provides a forum for pharma professionals to share information about how they manage their respective )] TJ ET BT 54.766 393.836 Td 0.957 Tw /F1 9.0 Tf [(quality and compliance responsibilities with regulatory considerations. Topics such as regulatory inspections, FDA-483s )] TJ ET BT 54.766 380.099 Td 2.191 Tw /F1 9.0 Tf [(and Warning Letters, GMP manufacturing compliance topics, product technical management, and similar topics are )] TJ ET BT 54.766 366.363 Td 0.419 Tw /F1 9.0 Tf [(planned for discussion -- all of which are supportive to the work of the quality and compliance function. Topics previously )] TJ ET BT 54.766 352.627 Td 0.000 Tw /F1 9.0 Tf [(discussed in Regulatory 101 include the following:)] TJ ET BT 72.110 331.430 Td /F1 9.0 Tf [(1.)] TJ ET BT 84.766 329.891 Td /F1 9.0 Tf [(Environmental Excursions and Drug Product Stability. JGXP V23, #5, Sept 2019)] TJ ET BT 72.110 317.693 Td /F1 9.0 Tf [(2.)] TJ ET BT 84.766 316.154 Td /F1 9.0 Tf [(Drug Names Categories, Approval Processes, and Problems in Use. JGXP V23, #6, Nov 2019.)] TJ ET BT 72.110 303.957 Td /F1 9.0 Tf [(3.)] TJ ET BT 84.766 302.418 Td /F1 9.0 Tf [(Field Alert Reports, JGXP V 24, #2, March 2020.)] TJ ET BT 72.110 290.221 Td /F1 9.0 Tf [(4.)] TJ ET BT 84.766 288.682 Td /F1 9.0 Tf [(Drug Name Modifiers Definition, Categories, Generics, and CAPA. JGXP, V24, #3, May 2020.)] TJ ET BT 72.110 276.485 Td /F1 9.0 Tf [(5.)] TJ ET BT 84.766 274.946 Td /F1 9.0 Tf [(New Drug Submissions in Major Markets. V24, #4. July 2020.)] TJ ET BT 72.110 262.748 Td /F1 9.0 Tf [(6.)] TJ ET BT 84.766 261.209 Td /F1 9.0 Tf [(The Basics of Post Approval/Variation Submissions in the United States and European Union. JGXP V24, #6, Nov )] TJ ET BT 84.766 247.473 Td /F1 9.0 Tf [(2020.)] TJ ET BT 72.110 235.276 Td /F1 9.0 Tf [(7.)] TJ ET BT 84.766 233.737 Td /F1 9.0 Tf [(Preservative Efficacy Test. JGXP, V25, #1, Jan 2021)] TJ ET BT 72.110 221.540 Td /F1 9.0 Tf [(8.)] TJ ET BT 84.766 220.001 Td /F1 9.0 Tf [(Biologic Non-Proprietary Drug Names Terminology and Format. JGXP, V25, #2, Mar 2021)] TJ ET BT 72.110 207.803 Td /F1 9.0 Tf [(9.)] TJ ET BT 84.766 206.264 Td /F1 9.0 Tf [(Drug Names Reader Q&A. JGXP, V25, #3, May 2021)] TJ ET BT 67.106 194.067 Td /F1 9.0 Tf [(10.)] TJ ET BT 84.766 192.528 Td /F1 9.0 Tf [(What do the cGMP Regulations Say about Recalls? JGXP, V25, #4, July 2021.)] TJ ET BT 67.106 180.331 Td /F1 9.0 Tf [(11.)] TJ ET BT 84.766 178.792 Td /F1 9.0 Tf [(Bulk Holding Time Requirements. JGXP, V25, #5, September 2021.)] TJ ET BT 67.106 166.595 Td /F1 9.0 Tf [(12.)] TJ ET BT 84.766 165.056 Td /F1 9.0 Tf [(Animal-Derived Ingredients, FDA, and Regulations, JGXP, V25, #6, November 2021.)] TJ ET BT 54.766 142.319 Td 0.966 Tw /F1 9.0 Tf [(Regulatory 101 will be successful if our readers participate in its development. Suggestions for future discussion topics )] TJ ET BT 54.766 128.583 Td 0.372 Tw /F1 9.0 Tf [(are invited. Readers are also invited to contribute manuscripts for publication please share your successful approaches )] TJ ET BT 54.766 114.847 Td 0.784 Tw /F1 9.0 Tf [(to quality and regulatory problem-solving. Please contact Coordinator Karen Zimm or Managing Editor Stacey Bruzzese )] TJ ET BT 54.766 101.111 Td 0.000 Tw /F1 9.0 Tf [(through the Comments section below with questions, suggestions, or topics for discussion.)] TJ ET 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 436.561 147.750 110.250 re S q 146.250 0 0 108.750 65.266 437.311 cm /I5 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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