International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries by Siri H. SegalstadInternational IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries by Siri H. Segalstad

International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated…

bySiri H. Segalstad

Hardcover | December 3, 2008

Pricing and Purchase Info

$218.00

Earn 1090 plum® points
Quantity:

In stock online

Ships free on orders over $25

Not available in stores

about

Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.
Title:International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated…Format:HardcoverDimensions:338 pages, 9.9 × 6.8 × 1 inPublished:December 3, 2008Publisher:WileyLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0470758821

ISBN - 13:9780470758823

Look for similar items by category:

Reviews

Read from the Book

%PDF-1.3 %???????????????????????????????? 1 0 obj > endobj 2 0 obj > /ExtGState > >> endobj 3 0 obj > stream H??WKs?8???W?n? AR ?=MO*?I?)+;???@Q?A">????=L??-???N?Tv?Fw?_7??O~?K?\?*,?$_F?K?a????*??????œ??r???QEQ?\W@^?-??4??W2\?? ??X??????p~)?,V?r???H_?0?????o2?/ou W???0e*??C?%~*???`6?Ce??D?`?R_N?q? )?J?w7]???F?+( ?Ypd5?@)????5}??>?%??W}Z?Q??w??????r???z?(?0??yiFj? 5e?:fG,???wf ???p)??H+??]P`?FJe`??S???r??#?`?K[j[?Q??tVu??sX?M.Z?:?+2}?m??l??????ZW?ZV??x?{$8?h ?????_o??e????P?7??? #?3Y???3MC>V?!@)I?3Zc $6?]XV??DR???l??9?+??zK{G??XJ???x????9X?>e12^kez 32???:?r??TH h?l?q[?m?1?? ???P7??c?,?U!?w???;??? ?Ya??u?0?&"%?|?????????_ ?>?fp?????.U??d|i@H2n????4?v?}???7???? !E??9?>%??&b?p?c?9 ??z1????dt,?????T??????????k??P |?X????/3 ????!f?}?d?6f?#Z?n$??n?/m?/??Rb?^?p(????$c???..q^08???? ??zP?D?????la?? ?V???CoBeãv??????????M?[G?1M??zv? ?c[?~??''?????/\m????i?w3??l?{''????oN???9???2{? ??2G?ib?f??h.ž????9[?t??JfH?SBCG???D!Rn?":???h?p????T,?(??? ????~???#??N? #?E??L??6?U?t''JC]???V????bH/|?%??B38??:??N?vk?jR??\}?N??0?w?S?VAO{?A??????g???!????W? a?3 ?Hg@Mr??f2R D?5????y??3????+, ??D? /????d??#???b???>??q?????x2?x???n?2?&)?e?m?u???cF7????0???fH?? zi$??? l???????J??E??????O???H6?I?l?Ko?B?J??,?n?''I? ](?c?t4?J%itr/??Ce?OY????f?O?$s?z?U??r??\?B?A????p?t?s? ???:s??@??T??fy??(?N?? ??? ?`????''???aO?????uj6????S?#q?\B?\??\?-X??????HjGI?fC?????z?? ?{??b?d?jor????r-@? =?C{?tw?K?v?AO"Er?$wgf7\?A??\"?j??v????3w:??H5?4?en?h???v*Y???%??E?g?o?j &M??qy (\?H??}P!j?tõA?s???!?4??????.?g(?m?W8?????Y???S? ?''?Bv?K?E?ED???U? Y?0?#? ? ??T??g? ?x?F?''p3???2?S?*?*m??|????%o.?m??.?2?~?_&r??h?? ??yD?????R????v]?IPd+?J?????P)?]B??V34?''?#????z??p?WT\aJi[m??? zT?l??HhQ?''x#?5?(?"???r:?H??wc?!????sd?M???S4C?GSx¶xUS;??y?3x?eA?y??b8z?''??E ??p?????uY???/J??l?A:28??W??/??= ?qE??Y x[[:ym??Ef??? >"??]I? ??c?"?J?r;?????? ?3???D?P9?b???O???8?,J?[YGyD??:????Ie??7??jRZ??h?@?{Z/????????+???"!l_w?YO/??L+N??,&??J??Y(??egI?O??????x?d???e?b??"?b?]?%''? ??$e??T? 5???NE?,??k?v?L?,4\???:z?zph????:??? I?T#?@l?f??!7w??w8Y???????)8??L?E?4Z7n[??U??6?By?^#]b?$?_?~??\+?e K''Y?W????m ?P?? ?k?N??:U_i%kR??? > endobj 5 0 obj > /ExtGState > >> endobj 6 0 obj > stream H??W?n??F?z?9r?f?????J????????CjIN???K?y?|U????? @ HbwWWUW}??zu??Z??js??E???S???"Kr_?T??`?={q}????"? ?? ???G?V?\^????o?8?Cou??e?????4[??? ?@???~It??????;?T ??e?G^????k??\3}?`L???}?= =?;?"Yy??:?3O??J??m_????XXj?3?6??Py?????k~?? ???{???GA?8?Z????_???L-??Y?q?š??b?6????de???fV??b?-??E^? F?HR?A>''Is?*?r??\P ?(?09Q?uc5?(?!?4U????L?#?E??J:?H???????T???E?? 6??AI?-?,?FFX|)??G?????5????L?~1j???(????I^^??????iYz{h???ay???? ?P??????o`'' ?q???=?G???P?+?}Y??XWe#?R?v}????7S@EX,`?0e??? 3?AL:?b???ZD??????/+?As?U?X??S?i?$,G?z????o?6?yi??UQ??qJ??>???DY?4"* $,8#? N??G?L9?D?Y????Wl?????8"?J??? +K4o?%1?-J?|?''6???2?N??c?s??v,r??G?, .L?=?N???o9n??j??f???!~b??$???Rj??S????OK?6t+~?4?D?S??????Rz???{?b?r???K?:??J??Q????x??)5???b?????L??b4*}???e?]G@??T???`K??"@;?f`??/???.I???S??>???{?1H?bLWM?mG?>?74>?I!;{8?V]K?s?afmKL\ f?V??''??8idZ??r???''?/?vi? t?????4?1D?B+c??9?????z?V???6?"dU?Q??????W?u-???T?c;tX??O?GP?{?v??%$??WNu'' i???]?L8????u?N??S ?K;?}??H????>???]?r???n?tQ?????#???????X????? ?"2??J)????''-?\kS??Y??e?tZ G]W*qf??f?Y?N?@???R?x?#,?za0??n???z???W??T?9???7 ?Ug1m????z???iEM???|:?)jA???=?"??|???C?u??m??j???>??[?N?!?NCCl??;G??o??S^U????o?? ????R*??fP]X?]?U?V+??S??(?% 3S?*?:`? ?????a?6 ?tig???r??s??0dZ?S???????84??*s]?(#?6???S7???^???9?''??%?P??i ???6?? endstream endobj 7 0 obj > endobj 8 0 obj > /ExtGState > >> endobj 9 0 obj > stream H??W?r?8?}?W??h???>9??$????JMm9y?IXbB?^F???????$[???r?&?Fw}?t??rv?V??|?8S~?F? ?C?N????T2?L*????? l??1\??4?U.? ??r_¥?E??? ;Q??v??CC1G??????k??" j??,NlLnb/?)??&??{????+?b?e~?TL`??RE> `??&R??K"??E?-dE?Q?Jb?? Bi?g????QS??)b?oC6 ?9?)?u?a?u?g r? ?G?2 \?a?d ??? ?=???[??Y????q?m??p?P?q?9?S??L?T!{pY?UA?R??r,?'' [>)H?????M???9WU ??}?$?1o?b3????q?6???uSNL????E?ve????- NP69O&6?yNl?8 sG????1?s?????=? ?M?HL??Gf?e?%G2 ?o??L*zID5? E??5??vl??????4??`?%`(?WS}??N? R?|?VRQ???0u?D????1?N@ww??G^B??d???n??&?\''????a$ax?KCZ??4??2=O?j?K?????\|j?I?:'' ;/fo?p????.? A??1YWE???pv/;???Y\]]~?X??????vn?O??s?\z?^(Q??~?.??OG?we??`A?L`??U?w??V.???{,f??V?5A&+ ???@?y?Xl????CUh??0ph? q?PL>????x???s???3?4?E?p??v?N?{o7f?p?%??0>?0???9,?;??bt??;=? ?-A>?&o?K??4;????C??bT?l??=?[?? s?02Q J:S?????6?t?/???b? \?v9oI)???x(?????*Z?9O?\]???%?cN??w!?q?wl?Qn??t}?n?G] c? ?{?"???0:?2??W?h??v?l ?????2?X?v?e???-?.?:]?{?x!?m?:?1 ?I???"F- ?!&?I?? s?!?h??? \????????[?uI??4????l?E?JTMQ?%Ve?rNXwOÚ??D?vhj?s4K?Xa ?*?E??{?0??Zr??Fx&????8?g??N-u??5?O??????''`e?[]|?+X{?m0???Q??`???V)Cd?O?@wl1''`C>?C?N?-?; U?(I\? ??? *?P7G?(Ad> X?PE???Tm?W?oZ?fe.p?? Ob#?z?i???h''b?Z?????*??X?k?7''?a??(i???E%6!\? ????|?]h????w???P?!mr?Pw??u??@?5u?i??9????axS?@??qR??[^?)x??o?????$ ????4???t?M[?+?8*v?^?J.=)% b???h?q?[?z{:??O??,? ??r,?Mi:(?????"??";? ??/?(???E% ??RVD?l3?i??5?????????x?o:?8?;??P??1?N?s?J??_??x?M????}??Cw?}???]k=[??1?BI$&^???l&!v?Bw????P??*?s?y=v?aZY7RW,||?(?x??t.?,????d??^ |??X?#-?u?;r??c"S??O?????> ??F?c??vj?ui?G?g?yt?7@????5u?0a?NW96?I?E??Q?''_|?9~?? :??? ??????????? ??NO ?P?#{??V???(?a?''Ja?_?????gHq??U) ?&?A?T??T ?}?p5?AT?io??*?n???8??j?h?G&adkA?l???o1U????y?lb?9??+???I:?^?y?K ?K?jK???Q??A3F?M?6??????SW??;???g^???l`??d?t?u??f??Y"D???J?^??nY?ZZ?,????`?To^????^Lv>?N??$>??4#???.?SWÙf???????? Fv?? ??.f????P3@????????%&?????? endstream endobj 10 0 obj > endobj 11 0 obj > /ExtGState > >> endobj 12 0 obj > stream H??WKs??\?+xS???m???8V?????}?HH?? 9;?XQ~e??????ò?R?l4?????goe$????M?\Q ~)S???D?))p????????VF??&M?4?m ????Gq#_?edb???,M??^O??`#?\? :?D?yK??&?%??HUI!?? ?wC?d+FW?]????mO??8?l$???v{?%?*??I?I??U?t????J??L?,?l??XuMu?5?P? ,?????w?????=???O]mH?&?*?e??p???h&A?7??t?=?S,?3???`??|??P?>V?}U???????2Q?????Ap????=?? 0????+? ?Du???/??r?M q p?]??]?k;./?????Hy? j{????s?M!?bE?ád???4???q?z})?l ???T????5??-?.? H??-???d??4L?sY?R?? ?3@l???q?h???v=!YÏ???b?[?????v6??z8??[??"? ?z B?l7????h?+?pLF I?\X}??Y?CT7?D:?@?$?`????S?6?"???u????>???????[U?+?5? Qw^c???#?a? ?n8??I?????d??? D?? ???D?9}?#?;Z???FR1?h7??Vh????_,?]U????''u??@ë????? ?''??????"??!x??a?N???*WY?l???F?8??6C3N??]??O?2?[?4?w ?["????W??"T endstream endobj 13 0 obj > endobj 14 0 obj > /ExtGState > >> endobj 15 0 obj > stream H??W[s?6~???#? A2????:;????''4KL)R%);?_??k? @R???t;? ??\?s????7r!??????O?Pe?"M?PJT?h?>y??J.???YFQ/?%l/?O?t|??D???>??P??y?i???d?*?.?????$?E? c?.@?_?]f?? d?u??Z???bE?&4????? SB??)K??2?Va*?|.??f??? n??l9_?9o??\?yG?Y???-??E??\T??\?q ?U?d?7L??? ?J?#U1?YE?&??Pdy(?i??:??9??B???;sA1k?*c9:?????????L??8??t&c$?Ef??D ~??I???K?a?eanLL`s????0i )a ?%^??gRk-~?u?????4 3qp?x??U?*?UO{?F?X8???$???!?q?1?I? s?(3??? ?"c???j???$????:?.?r?E??>Gq* H.w67?-??h7??3 2G???@d?r?.??????J????x?3?T ??zIG3??~??5-!???8?????{?????L?@?96^????h?|???%?!?õ?8?L??[o?W???d???m;?W?S?x???}c???v???f(??_/??????l[?? I]?~(?y? ?p???+??X??&????G$?#?I?_?????????I?{??*?q??r?-?+?X?:?>??8?$? F???:-? ?qLF ? ??r???~M^??k?Tnw;(?t??ZP+??kSK@?N?''3?{J??u?&j?%j?:??_0x??x?]??:??X?????S??yK?e?E??)?n z4? Z???>???A?T?e;??ot$???[ #(db??)?4???@???''E??]?P??{Qy?&?xa?oe????0??-?:?@? T??v0?]? ?e^????a??????d?5?"?M??? ?A%8?o?_?s4?6?????f4i?H??]??Pd??????9???2r ???% ?i????]}n???????$0S?OY}??\0????[e???????[?5&??i????E?Em??pC?j???^?hnf`?O?????S?? ??V??B?b??????A77$?Zo??  ?"?????i?~-??z???Lt???? ????|g???????Z????ha??_-???v=?W+]A??/?ae?????????$[?v[xyN9x??Dl?Va??q??X?xn?~??4]??;?P`?0X??j????i??F{}???z?{a???4 ?+?[Cc???-z?O??R??-G??Z??C?\?5?z?C?l??k/ ??????m??}{??c??N???k? ??ow>u Y>W%?7??,i"??%z?W n|h*?x??Gn?8?L/?@!?=1e62?9Uco 4????? ?h?1??_?N??qc!?:??L?M?c/` ?}?? ????t??n?0 ??{?"?@???M??w??[???n?{n??v\?a?J?:??|?"??pUx????+/?>??????????]?E?y }B?S???B9????E{??p ?!?- ?50=?h?n???[??]???~,s???T?t?????*lx?2h`??.|?c?W?????$N?q??1?W4?}@ X?r?B???]?I?qW%_? ?-?c7J*? ?1????o?_????CJ?t/z ?????:U?YjL?}?x???? > endobj 17 0 obj > /ExtGState > >> endobj 18 0 obj > stream H??W?r?}?W?#&e?????????V$W*%?CR:?L?)?#????~K?????8I?\??F???7?/?+????0Q?%?*??U??t??y$???"^?]???J????8??X??KX?~????W?K??(Z?8R??????G??Q?L??~re,A.?e???5????e?_^?k????:?a?`"?8??Md@1????hL I+/? ????2!?+)??????}p???5?pUM?P??K??=t5???5\?''??B?u[?Y=@?V??n?i?B???E?"?A?b????`Ro?j/?V?2?!?$2?B???HB?f#?(?"&??bi''?, iNTT???$????? f?T?(???F? ?Dn??M q??????a??Qa?&???I?t?2Y c ?u#~????-d??;?&?)k?v???3?Wv_??$ ?+????Q?YHh??\?.??@4??????f)? ?E@?????alFE?O?_''PE????f? ? }3 ??;VA? ?x?GYv??,??f??????6H??h?Erw?>EE?X????i????_"@??''O\1N`??+??E;?(\?6???| ??g?????1b1???/#???a?/???PT??+8??$?????????? CqPb???.?l?T%????\?? ?[b?v$Yf ?iK???? ".*?????s?z?????t?=yB??evq????8?????????Wmf?s7?>?xw??A-???i#????Ojy???]?/?s?%Fr?????EDi?etn?n??B:J?7?/U?????"???I?j?#?7N?e?@*?T????b>V?rz?T?[C3?e?????-??4;Grundg?]\]?[v??öv??aa?p?ro;?5o???I??,H?C?i?@J??? ??f? ??????#?''?B??N??s*k?D???????)%!?????uT????}??F;???i?????I????????}?eE??fF-^??{?T L?? ?0???Ò?;?V??v??Ç?~??P?>?n??? |??Q~?&k???3v? v7???>??;??????N?v?0??F,)??.I?E@?~?????\?_?^??????{ ???l P?N???%????`??:?K?\84?,(x=u.?????]3M3h+??9D???4?,???>??.?,???????X??x????(????v?_ ??bO??''-????`??{ C?r/.:???a???}?E^n?O?e?UnYY??2K?5????4u?1????e???F0??Y96U??^1 ?w?#?????~DJ?W??gl?/??? ??+]?xy ,K?01???;??iQ?t??.??????q???y????#j??? ???? Q,???n??????9?A?[A?P?-Z????5]?%:G1??v???+^???Y?RF?''???e?????:a??W=F?+zi????$}(??ZV????k????\W????[~ps??9#2I?3???o??????T?*???H ?????? vh??5n9?4]m+?nnIgN>??D?gJ"o"?,??cI??&G???d"???D???bD????A?"/`?????#?dw?b?\???,i c#mx??l?6??3???J@??6?E?^~A_?n endstream endobj 19 0 obj > endobj 20 0 obj > stream H??WIo?8??W?5?e??(*s?8 ?A?=q?A??\R??TII????k??y II^?@?a%???o???|ur?J.?b?91Q?i????}?XE??,??? ??''???????\??''gq?q?X?a{u{?A\?g?3??(?.?8Rb?r?q???d?)?-V/?nK??c%??????????j)SX?,?H?b Oh??$z`????:|L I;???@g?ZE???au???PuA??-?XV????j?R??j???"]^?@????L?iG?Y???,>|??\??\EI?KT?t?&???????#S ?YE?D&?a(lI0?Hb??b;%16????3}(b??\Y~G?_?dg9p0??2?l?M?~c????? #?.6?:y?`3 6??$6?)?? ?e???^??A?G??Z??X?jp?D??2Yq?d??vA??,??''???R?l???g?gx ????RNp^!??j?R?WfU?1??4l?n?X??? %???W?/|?Dl???X?N?o??2A??SzY@?>?L??????9???? (??? 6???I????S2sJ?Gc?JS sH????R??3"?l?Z~9???2????k ?h {=t*d?8?~RI?78??bW?}?u??={I?u???h?Uy???''XA??zj#???{l?!???0??Qs>n6m?''?N??m?????B??X?x??w*??''87U4/wg8(o???e??Z??w?O??????"??p?????ULf)?? n?????z?aZB??????, ??j???j?l8??Rc{??\?1^???}u?K???D??|y??y?:^??? q)?S(!??j5?k&:?àrR?CM.??e??d?V???9?Y`kA????MF|??)^ {?2????8(?R?~??>-Ce?g2? qW??|?OdA?????????h«?F??HG|`.g??Ar?,&??}??;hg??]H/?.??:?,?Z????#E"?"??4???T???T F0??Q?7???X?e7N?~%9?@??UJi?IB?[???%Sf @;} ?IP???Z\3_?G?^??W?Q?LR\??Q{6?|Pm1????4?i???? ???n`sN?a''????3????O?k???" +?p&*?R4~I?koR?M?I???S?Ry??Ù?kPX?M?!?aRP??????d-p?0?Zf3??/i:?f????d?X????d?rWP??L?Q??X?5?i???9?t ??j>????B???j???f$?n@'' ???&o????B????t?l?G????b??|?s? .7????o??b~O?9P]?????P7???N????HQ?&???`W?k?d~m??7}?l5N?p??k?u???nyfU( ]? mX''Y?o?1?7,???=?un|>???a\??PL???r)Oƒ?b????t?? ?pYq?6@????U_????3??c?}x??r??*????-??????n"???J??p???1R|?A???a????w?J???;??v&C ???A? ?Z??z?+?I?]?? f -{P?v[5???)?K? ?Hc???u???|???µ &?D?$ ?6H???ow??5]c?w?[?OB?''>c???In^??I???J"/? > endobj 22 0 obj > /ExtGState > >> endobj 23 0 obj > stream H??W?r???)?;6C?$H??\??L?n?L?'' ??$&??T?)?9? `??b?n?? R??h?b????5????? U$D???????I)?RQ|?L? J?v??J|0??*R???(?{]&)???l3?CS?u??2?cH??jdk?S?&7???Ie?E?L&TsWsGlM?1:?FNL2Xk?a?j??0?#U???4]??O92;?????š]??]??E?y[7?????h?5?X0?BQ???(?;????%?q?;?Z ?5X w????$8???Zo?r %??{^ l? |?:?I???G%??8??,?w"d?2??H?0??}???t?O?b?k2?? ???)4???"??6?J??-{S??U??&YC?#1''??t^?Tu0x??&?x???^???P????m???????/_d??t??7??@a? ???6?M????j+??8?m?O?b?D?9KL??a?t?F$.??o?l??b??????oi?,?Py??z?''e?N?u^?e???CEI2???s??TJ???J ?a?=?-??!JD???K???????a?6+''?>???y??z?|?c? A\>?#S ??JI????|\??wt??:V??????+K?Kf r?Fc???O?!y?????????5??J?o??FD{IG??`?"X,U ?y??{h?d?#?N??/8c}h7???5?c?? ??SUH??J?Y?y?/?T?G ?-B?$??/]?u??ELV??^2D??4i0? ??U?\??A???O_?5h??,?%??|?i?? ?>?)& ??~y?NR0Z-???V??:??lJ%??BC?m?QQ?TT?.i5vI"???8?S''muml?bxFqp?W?u?????^??R??o+YI??r[??O;A?IA1CK?J)?$J???????+?}?^?,7?MntTf?.?@`N??2K@??W!?l?a$???sMl?W??l?&@??E??dm?~?e?Zj??0 ??/J??????|]Z???lU?#w?$?&????>?p" ?%[??nNgK?4??g(?0???|??O??5?P=V????X??*??7??''??5?C?ZMS 3U??Z?2??H?S??_&???a^??iw2???"?eP?7jR&?Ix?B?M?s??)?2?? ??FKQ?7z+$]g^K_??[:?Q +?gQ???F??Q?T?w7''X`#?^?h oV???Y?%?4$j?;??DAQ!?m?? ???a"?jm??f L???d ????b^??i?l4?~?}???U??iu????????7 t?N;??Y8(E?~??1W?e??.?X????%?C???E?Q????W?Dx7 ?Je???rd????O???fa endstream endobj 24 0 obj > endobj 25 0 obj > stream H??W?n?E^??H???u?i??gw??? ?~??m?O.?q?3y?oI]HI?w`??Y?bU??:z?={?A??j{s??E??U?QF*Ty?? SP???`?M?????-Kr9I?0R??rz?tu;?n???????? ???P(??Ro?!_?o??s????e[Q?:B?V?VW_???L???Y??8???*??d??????3???C?b??,?BN ?????"??a?/E? ???????hDJ??a???3H??GJ?6R?? ?°??a2Z??P?%?L?? {[+???C???+??6e@?????v??(L?????-#??!>????B.}?-? [? ?U?K[?fx???^1???o??8????*?/q?d???G???????4M??[B&? ??H?6?0z~?r`?????{?@?????1*{??kN? ?????g??~??/?.??+?ta???n????k???P?z??-??q?&?????o\/-?????O?? ?"??????O???sR????Z-????6??Mc9?-??)?????;? WZ?V????6n?@??na??? ?Y???C,????3?!u??*????1E??? y??? ?l;t??p,o LI??D= ???;??????t??v? n???VQz?)_*!??A??#???c?4]Bz?dE#?O?????W7gs"??iº?ng???p??my!??!+(h?)?b??*?''.????????;?''3?u????%Øg?????}G???z??????U3?=??''?? _>?K:??W???????????Xk?lE?C?i??@?a?;?%????_+?: ?>? ?g}??S??`=q? ????????) ?0J??u[wU/?0QE????^?db?+?%?jz?a?}??G??e;?0 = C??z?b?1??Ab???OIIv?1??(???{??? c??L^"?a???>z?MzGD????????@9?n?Q?na:? ? ???_???E?0??H?_o????]?????f?# ? [??OI?????? ???????L@:???iF!W2???RoP??M???>vY???6-??PO??vh>?g?36??p??! lW???(?*?????8?I????t?[? ??P???z?BH????R?oU???? ?d^VW;???q???A:??????-y??LI?~???}n?X?I?O?d^?e??*''??'';Na>y????.?L?T}H?]??Im?p???G????.???sn+[??R ?ok? ?Ýx?w????)JY}???U?????:? > endobj 27 0 obj > stream H??W?r?6??)x??,??H? g?iT5?B)Z+U?r??t??\?=?W???R??''????x???*o??~?????T???J???W??i??%H???r?&@"?} NE??? ??????9nfzP ?Q??a??Dyl?kk?" j?T?~??3???%2[?x???,?X??"??-?s?b???!??4???????;?h6???G?Gx?6????????b4???r????}??n?D???_?-?&C?=?{?9?CWi??????]??`a??z3??D????2?P????? ?E??lN?&? ???dQ??2}??=??c&????zl?x????????8/Ri??6????~?O?jN?0?? ?O???2Iw"??wm??^????wn??krdh? ?oU;w??W??a,???*???V?x~??]j?8 s???=@ ??Qv`J@??Q/%=?b; ?7??? t?k?g???????L??l????$?W??=?7?*??" )?\ ,?g?sagR ?q??9??-?2S? Z??i ?x? z??Oy????3k]mv? ?}?~./&}_????O&b??,???2?d?* ??f?????????(p?d??}?x??E??wEF??^bp)?5???)?c\?G??)h?au:??N?29 ??pM?#???4S???U?>,??5Dv???????7??&???4$????AY8?? ?P|?g/?8Q??z?C?]?-R_?S?????????p?9?W5|?E?y???3%4?f?(??wM%????j?{EHv?;N-??ch??E-?v_? Frf? > endobj 29 0 obj > stream H??WK??8????j??m?o?4? ?,]?F?Ae?? ?j???2??H??f?e??u?e ?k/??Rm?eE?G??)?)???~.?6?7k??Vz?FJ?y?UJ??O????\???L??????=?#I d??? *8?f\??T??D|E?f?o??V??I?GU???:Lo?@????m=N??g?????????R??q?wC?;?H?U?V?s?E(???F?U?k???FyS??wou???+?I??.?D????6n?5???g''?$??????8?N???)s?^?+???\ F?? rv?????P??"?|q?@?d1?? ??io??xD*?/?}7L.??%???no???8??M?b?xY???HIVA?f1f?3}?C(K??b?0?\fx5qUB?[??5?xp=??}c?tS?[H?? o?MO?=*0V''??i??}??c??9???(??Ý| ?wc??4{{?u9?z*ll?%??%y?5h(???DA7?????????@?_?k1gl$??o?t?A? ?LI?) ??''T?oG?I /??w?????d??5?B?b???q ?3X??H???l?V???? ?t??o?D???9{?????? ?H3?q?e?? 9.?(?????????????e???r ~l?n?W)???n??X>M-R?z}??????a??{?Jct?????,????Bm??q?5?ovzB{ ?B??R??O???????|??D?? ???*4??1V?)?JE??D?-???8@?3? b{Z?p?N$i??????f?X????2zK?t?c?w?i???u?`?c3Q???g????????????8?s^{????9????w ''??N ???R?r??n??????^Z?o????n2????v?`? ?? *=i?0t5''?K??g???u??:???L?q?,??Nx?N|T?8??x8?9([UKh{l.?C??X??s??????n??R????''^??%?W60??;?_??}????#G- ^????S?2??^??Q???&? ??.?o1???K?A??$?%?bD?9???E4c?$??I?????}?????????Z?mR? x??e?(W?U?)??G??,1x?y9''?q?r?wuc?????i?QtRz????: ?1? %?a??????(?]k endstream endobj 30 0 obj > endobj 31 0 obj > stream H??W??E^?+?(3??(?o6??????"??Z3-?Zj????;w_?-? )?/??`a ?&?UUS??oVW?o?''????M?2/??SD2?Y?I !AjyW??~?Cu?Q?????????I? nd"????Q(?????=??0?:?V?" E"???????"?n>??H??C????0????-??P?b?/?vSvhL??V???A.#i?????~??U?Pv?????%?pU ?P???*x??t?Vp???=??[??? Z?o}y?+?U??a?B?bF:???N ??W_??>RC?H?q???@"3????"Z?0?": ?Y?V??bV242c;???w? ?d ?{?%?f"??L?Im?X???;%?e @?S ~?|h??d??????~?5a ???2?? ?A??m????w$?F?|_ny]?cq?Pi.?I??????b???v?y''??q\s?j?]????9????.??ou3_ ?, |-?_PL?Q| "?CJ??vA?z??,??? 3???&???+????k?oé&8?d???.-s????,??}???; o?:?+???~(??n?c9/%?? ?r?q9?H?"c8?37???\??H?E-?"???Q?????a ??H??e/q?T??F??)?}@?*??+i??? (Xf???n;C???R?h?? ??$t??1^h?k???,q??X?kT? ??cq????PW??dJ??p!??cU?H?bN?]??K''?3?Y? yY-?? ?U????v8(???Rc;i7JD??Jg#??m{?) ???`?2??tQL?,P ;?ImMEx?c?|A* ?1(?i?;?????N??Xm?j&??,X?\d|??????A?P??A??X?1?tuI???.M??amc???FY?H9?3 zm?e80?|???$y?????w+?]??y??{84??s9??w vf v?_??T}??t????Y?D???#?k? ?k??''?L(?+?? ??t??? ?g?fN=?p~Y[????%?8y?JB#?@?k???????b*V^?q?h7?? ?@0???-W?*l |???Gh????09?\8?/)?ym??^???Ry??$?R???B tn???"?4? )??o?!?ly?})????7v??????T ??~~^?M;N???$?f?N??&?Lx???7\???????el???e5?n_@;r?XfV?nZ #A?&((*s|?X?\?????c??kL\??\M,??''}V??1???yt????''vZ?4??L1??3{???f??Y??r???M???-!??LI??4Kf N3?{??.(?hiP?&#R??!?X?K `f}`M??W?Ô}??&l''~W???}\8G?pC????Sk-??P??J?????????}{???L?? $?y?k?????????,E?q:K??sV?q ???t?O?t?????AH"????fGa????}?u\? ?(v???d???A??X+???0t > endobj 33 0 obj > stream H??W?r?????)x??v??^? ?????4?t??$?`?)??????(J?L;????????????y/?r x(?????,??O??s??~(?&BQu?^?|?''???7-SB??[??2?V~*?|#???-???????T???5??A???*?q?1?t?\?????cx$?=dk|5????H???(W~?B?"?I ??2??E9??z??Y?=e??X???(?#@c?? ?s??E?g??m??~???''N?-o{?h??8SU?C!???7??>? ???g??R?[????_?0_jdn?]w,??^???G? ???S?''?$??_?]=3(]???ia?r5lT?h?#8?~??I_?L??q?i?$?Gt??x(?aO ???b??S"Vw?''????~ =???R$f^????~??_??N?gx5?tJ? ? ?`3?p?!?{?W?~???D??G??b~b?j? S?1??b??U???? > endobj 35 0 obj > stream H??WKs?F???W?8?a?`??!eK?b?+"U???D?"bP??+s?????? ?r?N?T==??????gr"''??Q?$L''??G(_??$?R_JR?`rw??|&''w??4? ????G7?R??*?~$?{:???~????S?''*N&?S?[?@?Z??P?????4??rOF?z?E~(2?Ti?%??~ ?Q~?V?y??)!i?O??R?V~"?|)e?vYe????xb??iqU??P??I-?s???7sp???A?~??? ? ??????8?qY xuj??S??1???5??#?zmdP?R?h8.~?X???U?O& ?rq?@????-sr%????I?K$8???L,mt?Ng??u?p???q%?OV/??M??????4??K?2?}lI?O??6??&IN?HJR?X)???????%m???L???a|?&=?4?q??v~q?_?Ae?s?>?t?a??4/???4?r?]V]>???Pu9LC?&S?DJ?!?!?r???C??t????C?w?=?!??v?? ?"?O!\E??5?q=!?0&???n,??br{(?;>A?i?_????;???[?gv?g??? =?m??|U?r ??g??R?:?x?Y? #??s??1???mdp?K#Y????r????=?^??#?????t?}??@we?y????k?9??Ym?]gEi??N;?@d????%?[?????????????+?yI????v[s?~?Q! ?\\de?(?~rb??????a??M?|?????e??b??+G~W?A(?)7"??q ?]i?n?Nq? ?+\?L??}??}?t?FYQ?m c??_X/9?j??IQ?.?}??B~?;?:Jm?i?''??????&???%?YV?d4j?` t??K5??\|p?Uf????#?o?Vru8??C?!?E_t.M??Hg?$?)???3?Q?@33?5???"R?[)??R > endobj 37 0 obj > /ExtGState > >> endobj 38 0 obj > stream H??W?r??}?W?qP%B? ??I?d????X?R?>? D?!?%;_?_?????B?vn?)???LOOO???~qr?R?????CY??Y??O?P??,??PJR?h? ?Aj?p????$oC ?Q???/SB??)?,?$??DH????????r??? ?@e??t???:P(E? ?n?%????s ??U?g???xkv3{?K4[??Y5;?Thp?Qad??_?1?7??N?~$??%H$&???@"?B ND??a??El?l|O?2???Va?R?Gg???e? 4??Ri??$?;z?0H???? +?/i6?qw???r??af??`s???!D??& ,$k^??6?K????._U??D??D ????q???E?]?Y??,?fs?*?0#??? `p%??R)C?????????.G+???`-??&?v??+ e?A:?m??????Oy1?e[-??%@???s ??F?[?o6A$H???6?S?]?s2]%S)i]b???*??%?? /?fC??2 dnP???C^t;H???s????u?i????j?.?n?????9?????)?`6"??n??dh,C~???8??_??K?u?(??6?2??(????#?>>??_???B?8k??f?u?L??n?0??,?Ae?????;O????jt ?k ???A?I5?zy?MO?s^???????=?^(???x??~B???o$"??^??q)S???? E?y? ?(h8?? n??P?z??q?F?7M=?XU5?L?yS}G"?*?????K!?6?\C???#v?X?&B"?K?+??qp????\?v}?9???ln?m_>?z?m??=V?U?) cqI??? ??"=??$??*P''????^ ?c?!?~??T?T??9$??TF?????IZ???qJD ?f??x?:?iq??m?4K?{?Y_?|???4=?*:???????a???1?u?7d?????h?ZM???"^?N(?????M,?zU????_{?c?B????iB?z?^Sj?l??syE?.?z?;?]?O\???-?l??j???T???>?W?@o??? N{?[Vl]E^?V??????tf???@??LWV???wW?W???M?pO????=??w??.????c????bC?G??q?P4n?m???B??w ?? ??? ?SE^?Grs?v??g?3?? O??????V??G???? ?f??????h??)?w?)?^?J1\q? e??3^0,???;?f??????3??O??\>M??]? ?2.??S? ??L?(w??_A?? ? ?Z??????E?????J\9??V???????(I?????}3??~?2?d??R ????>!???D???M$??^?C??[?8E?_??vT?I? g? ^X"???p???l??A?7??H^?,S???x???}r?c??f?l????&?? k??F?@???+:????+??m??????L????? *w?7v$?tr???@?-???@?$?? URW?b B?2???z7??K,?8Is???B?MLe??????1>?H''?vQ????,?YY??S??MA=?????s?|?m?M??Y?!???_x??^l^????3lxW??9B?,T???=\?:z?2J???v? ??????}?_m?M?M?^?TX?#????;?j?xk6?5??B?J???b??g?[?{?xX?N?G3+*X?g?&R6iS?W???o}?|??C:?S??H???ve??s??@??\?>(??R? y?? ?;?&??f????4??v???2!?}??y???????r??B???R?H?J9|{~?S????q?T>??? H? ?b?S?????r?!?4?Y?,o?Y??G?4??=M?I??? ???:??????T9?enZ?\h|?f[?gQ???b?C:?kV?c!?????;L7dE?H???I?N??`4m?,?I???e:???h??i?Z?v???????;?QH?G?\?iT?L[???C@????9AE?J ??MI-.???+` ??`&9???5???R????Dc?[????F????i2??]?2??????2?I?e*snm!{?hO9????W?8X??|???2Z7???P Bu(%Vvx6?@(??^|?v???Sov~??? ?@ ( endstream endobj 39 0 obj > endobj 40 0 obj > stream H??W?r?H???)tlnY4??;??q??$??X?-?h?V8#?.??''o?O??@?M???J2??T?b7?F>?_?O??? ???NL?t? ?u?y&R???j?r.@j}?M?''g?W|?lN?Y?e???? ??1}???#c??????7?%"h?????ni?? ?8~???,??m?WdLS#!??j$P?y( \???x?#????l??????8NEB}t*???f??q?M?9????s ???????:?=?A???i?ij??Q?xu_,??T???s?92??????R??o??5??GQ??D`X???\A{ "0?/i?EDnC???`,?Pfad?J?y?rSW????:??h>O\ (\Cm?5?_??5?0??$ Tq{C?-?N[nWy[??&VO|?????S?3???jR=?K#?yg??????1.K@?5?.U?.H?98? =????? ?kS''???p??.???]?????L?%?=???=A(?G??/??k???k???e?qx??^SFh?}??#}B??? ?????1? #?._?????? ?yt, t?$?$?MI}??B?X???b?????b?:j????k??eQu,??(???nD??3@??+b1?????`@,??tY? x?=I]?;??;? ??n?8^N?rE?N??g?W??W??3???`??` ?????M??H8??8(-?>??@??? 6?B??=?y3???o????Y? ???????&oE??"?????????Y??6Z?0?l?Bj?t?????b?7M??E??4(??|?G??G????o??*v?lLN?q??m^- Z???i??7R\???X??O?^?.?w????gHeKbX?d>??4HB5\??*???????`??g?\??????1?{E,??tY ???r?)???7^n??0H4?_?h????W?n?F}???r/?.?f??k ?[+m?Y?a"??Hr??+?I=3?Ks%J???@?DR{?sf?j8??N?f??b??Y?''??YFw??????~?[c?PJ??yK??~?p/?.)7S?.n???]???>?M?` y`U?g??? ??BC??El??K?????R?9E6???????wX??_?I={^7?wig#+??n???3??2U??v^?;??)??2?3 V???R??:?w5?r?? &???z??ZA????f????H1?R??Z?Uv`1?b????f?>O|N??g???hh|A???S?,?L?_?L? x??''J)?itHxYL!~R?*W??K? b??EQHk[? ??{8??????w^?9?  ?_?xd?????5???i?????Q?B???yAv?\??b???!????_.I?@71?K???^?????t????4??.???p ???\?gW????+%?$n#Jg??.????&??v?6?IaF??v?~?=R?0?",?T??z???|?(?j??O???i?N?-??]?????????X???^?E?@p??q????,z?Z-?Y?? ??y?2?N?# d9?*??n$???i???>??_?e?NOA Ii?JrGb?d)??9?3 ?;9?e?&4;??u?j????,?? ?Ln?Y??E`* 0?????zQJ@?+ H?*[9F????#??P;r??n\??!??*???T?;??/???T??Q(?''-??FU?&5?w???"G?T??m?+??9h ?"??36S??????^+2?9??N??9?????C4???"? ???o''P?`???OD?Hv;?k ?B?&???}(?8??Z??!???zNVg?-;:?NC??.????A????F?FW???&???L??hy???????z???? x??C???|?= ? ??q ????)?a????q ????w 0]? ? endstream endobj 41 0 obj > endobj 42 0 obj > /ExtGState > >> endobj 43 0 obj > stream H??U??6}?W?V ?w?q7?-?nc?E??W?jm?????|KgH??h?XX3 Kv29???|(Kid?7VJ,?0??x?M@S?E?1?@(?B?2/?X??4??#{*@???K?k??[Q??K?J?s?^?ÄI9?~???4t_?????i?7??@?l?M?*???*%?tq??????????yLy^?{?/7?????8z??b?I?8t?rSN ???1?U6,Cv}???e?~??) ?rJ??+:?x?sH?G??p??`?D?R?x$i-??9??1???n?T?Nr?b?O?u???(???.?k9??Q??v??~??v??????=J?]??;?$6E?+? ?]?w?D??v??$1o??|YmU -`m,?{?R????y?6?R???5G}q??I? ?J?????,??Q?????V?TW????WX ?=%???oh???g.?Jg?8?N3e# L7?P?+?C?8???R,?m?????nd?O??e?+a????C??||i????s-V???}?h?I"?tit??,$??0`?z endstream endobj 44 0 obj > endobj 45 0 obj > endobj 46 0 obj > endobj 47 0 obj > endobj 48 0 obj > stream  ONIFHP+RMTMI''???Jo ? ??i?o? > endobj 50 0 obj > stream H?bd`ab`dd????t ???/(??M????f?!??C?G????_5??Y????\???#??????E??% ? ???: ?LZ?HKC0i??????\Y\??[????_T?_?X?????2?X!(?8?? (q?Bf?B?BIQbJjnbQ?B~??Of^~IeA??G*P???Bb^?~~?B&PwqiRqfJfbQfj1? ?9????*???~?3.???}??M??''N????????Q9my???????-????M???????{??v???cN??9s?t??Qq??????''.???Q????P??[??????W9?????U??;?6???????JLf??u?{?,???yx 9??? endstream endobj 51 0 obj > endobj 52 0 obj > stream H?T?iTSi??%$\%F!^??Ir??"? ??. -?( ?.? ?D??D ?A??????" ?*.(?M??C??} ??Sk?[??? ??3????mf=????????=????q?9?6V6????m?? /??I?{????"H??B yn?2??? P?z?V??T?? ?? z?/??VX?Y0_??*dMq???6O?? 7????=?Cw???Q?? cq???bi?bav??&?+n?Z0?????{??Vo??p?1?0?#?8=g?_{ |ry???.?[?!? - "x)?0XW?l?????7?s??9??????[???1??|?,?4_???/?*???w?Y+]?q?w?m?gs??l?6?Pwvk{??????¯t@?gu?4z?7?3?.7YT?!?Y?c??:?(?q=yX???"??1J???u\??2Ry??k????f?1?N?? ?L ??(????c???{?d?AC>??Jt??i?z??]?o??h?ak??#]t???f?{?"???m?/"?$????????j8M?r??; ?v? ??/?J?9??!_?[ ???]?#b?G=x(?%5???m????s~?>??Z???9q?K?P}??yQ?ZH??7?D ?f??"|$p|?vs?U1M??]?2?$B~?"??F%~??"??hY???aE??I*?????K??L??1????????%??h#"?z??.???E?6>G>?=??n??u?+-?AK 6?????*?JU??h?K?M?#? >?????D?E%%??Y\i?{??Dbh?`!?]5 ? ??4????y??u????MO??tYE?Y?ö{??2"?J?R?? ??0???20?U?f?K????>?5}U??+?Q? ??N%$f?9????>??SN?~?4????$?7Lw`?a???8?????n?????M??!{?????m? ????I#?]??13?????????5(??'']? ? ???''?Z??:?i6xfEv6?6???*?Z???n?Q?"?8?? ?(r?''rC?@??H!?????\?j]?z?Ztuk?V:v;??????`;?s??7??~??????O?l4S4?''??''?p5?????w???? C? ?|??p?''???{?B"???d???\??[Lk6Sfb??d?????m?k3.??l??f??v?\?]??P??:J[?\?0|9??o>~?A5( U??(?j? ?|?,o????Hy'' o????^??}?o= ?$??uH????btv?h??^?? ?h??G??z?h;6??5s??;?,?=y?Y,?R?P?????U? W{??E$???%?P??I???}K???".????????$?k?????c?????? ???F+??S?%?S)?2????oY?h?L?e?3e?Xf?h???a??F?w???Zn??^?}4~13??)?%|??H??????OJ?ä?JU?????*?w?????^?WVX,?????D??#Q????z?S1??????*???????+? ???Z?Á?????+Wn??o??VX? ????$ ?{?p??Vc?o??B?z????=$????\1y??L,?R2Ww?n!:b?q)???-JO????q-?!aN|??? .=]=???PzX??D???*?J?`9??x?}K?"? ????%y?mSV?j?26?%????"???5Zt-??$?? ?8:S???#|????''???6?????????lzY??8,>?Hj8???2B????!j?w\??K?=? ????8o??VUi1aG?{????|???6?XQ?sO????o?????d,?L"?9??''V???%?c??0???(?9?@??????i?e???=?''?{$F?UI;?]vV?6?/?8 QTZ q? 6?? ?H??&c??Zs^[_q?z?jk??????t???~y?A??e@????,?~?T: _nE??????$E??x??t*?X[ftu??Us?_??E???????d? ?23?yY?_\R?X-p? ?K\???:?C? F??? ? A%?1??????f?T????w4?G?N???YX?_?gN?Ex?% +?>>y??`??Z?_S?Q?nu???O?=??0q?|???y{?vn?st????r| ?~??a ?~?ZL8?Ecq]Nm??o?????h????-??????y??~??s''?W??i3?w???M??>}?w???97r]??8a ?"??E s??K endstream endobj 53 0 obj > endobj 54 0 obj > stream H?TP?n?0 ??d??)??%my?v?+? ?)???}%?I????)?GM6???? ?,??M??[??cuX??? > endobj 56 0 obj > endobj 57 0 obj > endobj 58 0 obj > endobj 59 0 obj > endobj 60 0 obj > endobj 61 0 obj /This endobj 62 0 obj > endobj 63 0 obj > endobj 64 0 obj > endobj 65 0 obj > endobj 66 0 obj > endobj 67 0 obj > endobj 68 0 obj > endobj 69 0 obj > endobj 70 0 obj > endobj 71 0 obj > stream 2008-10-01T05:42:10Z 2008-10-01T05:42:10Z Acrobat Distiller Server 5.0.5 (Sparc Solaris) c01.dvi dvips(k) 5.95a Copyright 2005 Radical Eye Software 2008-10-01T05:42:10Z 2008-10-01T05:42:10Z 2008-10-01T05:42:10Z c01.dvi c01.dvi endstream endobj 72 0 obj > endobj 73 0 obj > endobj 74 0 obj > endobj 75 0 obj > endobj 76 0 obj > endobj 77 0 obj > endobj 78 0 obj > stream H?bd`ad`dd???t????q? r?q54 ???a?!??C?GL???"????M?? ?~Ob`fdd? N444q?/?,?L?(Q?p?T0??4Wp?M-?LN?S?M,?H?M,rr??3SK*?sr?@:??R?S??RS.```lg`,b`bdd????????o??A?w-?{?,, > endobj 80 0 obj > endobj 81 0 obj > endobj 82 0 obj > endobj 83 0 obj > endobj 84 0 obj > stream H?bd`ab`dd????tu??? ??~?0?g?!?#??????X????,???!fFF???????????g???Q???`hii?"?B2RBR# r?K??? @??? > endobj 86 0 obj > endobj 87 0 obj > endobj 88 0 obj > endobj 89 0 obj > stream H?|TiPTW}?G?n?y(??{=!??"???D?(A?FZi?n??\?Tt@DEFA?KcD??E? $?? c????L? g??f??''?+4I?ST?bSe?v8?? R4a?/"??a?S*j?n?!F?EB??}?inT???:???"Z|?1wi?^???-?h?`???J???? ?y?r?-?^ntDb?/$?`.d ?J ?C??6???:? `?H???j??+(???C??hW@????I%Iw??9?n]?e??H?CW82????`?c;"?{??o2??+????^?????^?jn????x~@?C ??E???????+?~???????{4J??o?ok?V? ?????`G??G ?G?3???.,????W`q??}?*y@?T??w?- C?h???[?Wn?????wE?v[??:????''?O????__?GNKr?r?y??^?l????Qf??8&L?O??)??} Z?L*?rjW?y?8GN?U?R?7Q??? Xt*?|4Ex2W?k?c2???{H??BX;?p?MG&h{?v4?T-?G??N???*?j???!??? ?bg??:?????????????,??r R??\d??iA?\???(C??D}I???H0?.d?N??2 ?&fRmeJ?4???-|? ;P?T_~kFg?B??@/ +-??????}9r??r ~??????EI?Z(;-9 ?????|?A?v?cI???D?kq???Se? 8q?Qn? LMh?)?%?:z?. ??A?????*yJ''?r}m?W?*%/?!??? ????(}?"M ?aXy???&?£VE]??_ cN?V???^?????8 ???P?~???S??~?;?`pp?''?K???-?I?x*??"?q~Hxy??6?F??R4???#?????u?!?@???f?N??F\??!?#? ?????5:???;?+?Q? ?CA?y? mR???s????:b?E?,FQ?STq%I?>^&??8cT?l)?????u?K?????s????????''?P\%G_K[?$?$?3??H?????MGt0@E7???????Cp4???6??3I?] ?qcZD+??5?=????:? w?i??\?AM?G ?>??:??????H?;?????Ok?w?5r+????=[?=.V??J???\ldDL$??N?7\,???F??y?*?>??K?3?????fM??/?3X????3? ?s??y!?\??????w??3?q?½nSKMS????/? ~[??q? #?N?V??%??k(?\bl???y??.`q??q??~s{ ??????M?y?yx?dQ????b??R?UWr???vr?{"O?Lq|)xJ^??M?#CJq?k?s????e?? ??9Yh?j?/u? ??+???]?QM?w|9Y?K?;? ?????;??L??nS[??P@????C0^?$ ?? [??[?l$?????y?????14:?/q@a?I]{?Rs??r0a??V?"0??????q0B???;?????U??r?R.w+{??9O?.?e??~p.??x?d??F`$???;??1V:?"C?????????m C??@''u?M?T?5???kks?E?R?`?q?&???)?????]?????>?]??v? ?Y?k????"??Z?D2? ??cy?h%?2?????,Jc????LGWUTj? 10N?2''?`?? 0??????Y? ??{?hi???r??????S?+???o+??F?` ??^{?B?wd???@??y??h??7?6FR?xY????+??}P9+???W5??????? ?P? ???E/I?0&????>ZTW???? ?v?[?U1?O''??:?????G~?^?j???E[ ]h?d??y??R??3 ?p?>????_???????2-??/???f?h?z$A??#h1 ? 8|?????????R?h??-?????|??;?sG??I??}(??''?d? LW?j?juEm??B???P\0????H ??dh#?4???:??j??*+?( ?T#?ix?1?rK?.??????c''=]??- ??K''mC}]??1?(? ?p ??\? ??u???i???f?DU?|?M??V??+?O^?-#????L; _G??-%f?l?l6?? $??]u5''y,??vb{?????Dx??? ?\? /?{??T??Y??kn?????&m?>!C????!Q?z??"} ???~? ?S &?%(gA?| >??????|???f?V??|?e?R???K???Y??G?G?gI???dSE??B????5?W%?O??cM;??~??êX??u7z???gM??h??>??R?V?h?n|??m??l?9?i?? )?Tk????Y?hlk?9A ?*???2???\?8?a??q?J??a?8+LsJ|?8?R?L? ?? endstream endobj 90 0 obj > stream H???iPSY??x??,â?Q???:?[????"?"k? !??%?? ?I?%?1?":??KA???{??% ?3j?0L5N?????GOS??r>???{????0???0???{}?}?? ?m?)?Da ?N???nDXR?6???+f?Tu????jZI*??5???3N}B> Q$g?U???r ? ]??>?|?p? ????,6%K?s?#d?????1??2 ?? g??Y|???3?F??h?? ????e??,?w6V?8??6?(?ob? i&o?]h0????p?GMnddj?ve??)y?? Z?q???k1?i%?E>eY?%?%*???????v-???4??9?>???IKyB?eF??s?e?%?1[?.X???B??I???`???O0xv??M\??+P,??whZ?? ?[???l???*E???4M????w)a?|?R?w>D??5~??o9??dh?? ?`?o@????,?_??+???????j?R ?sc????D?ep.0???Tu??*?#?,??Nd-E X0?? L???9??????8?z?+?1???{L???Z?I??u&?6????p?Dq??=?49??????Ãa??`q??_?^??[?,???A?|??????1ig?? ,?o??????''X?cf??q? ?(???????;?? ??z??K??:?Rq*88????y?{v??8hhy??t-Ng?T 9?h{62 ???z)????3V3?a? j[8C??c?g?O?q?]??????q??D???p?S?-??F?GI???i??vE??A?k?k9u]w>??__??*?M?????f?-??2?Vr/??b????M??y?_D?X???1???t??O?V2??h??? ?V)?''J?W?s?ZN -???s?? ?u? fq?3}BJ?:?K????}???W ?&V???B?.?wF?F??5?:YOf??u??T???*]Ec?F9RP????xY(9E|r???J_?4???????]?!''?Fu''? c??4????Z??? r?(I??d9???ks 5i?R?T?h??{o$?s?h?>''o?z?X??$#??s??g?i???"?e?i?B?B???? ?*????M?p?Me? S??:??2a?N????G?n;??Q?G?''?????5AJ????2>??(?)???y] D3d????qN??9??&\???;???5[??T??i????u?z;l?QH??K ?i?G???Q??8????U~?h????%2j??m?2????u???8K??6? ?????Ë?F??0?u?r?!????Rf\S??''?-?]??1?Q??$_???G"w??9?M???a}Imz???X7?o??? ?\g????3 FK???(4?ry??V???p?3???C?nf?r?¼;?n?)????G??!??+???*¸#???+?i???;?q??h#r/??XxM??r? *?Z?UgJ??????&?=|9?+7?4?rS??b0Z????}?^N?lS:?fJ?zAÐ>b?O?Q?F???????a??L????ts $;§????SM?????"%????f?^"??4?b`??_l38yv????m????yZ??7t????(&??????^G"??? G?H??? ?6?D?8?8???yn? x??q r???y?+s??XF??? ??K?m?j??eyK??G?(?\??K????|????$?=-????????lQ??k????6PK?????z?q?`????*?5_?>i??4?5??L}?)].V$)? e??? C^Y???W???,RL&?W#??$??m???Q???Pi!??N?f??;y''e_?I? L?x|?O???lT?%???0Z????KN????9?[?%+A????_?b?4wO??=?Vre~''?tH ???*kEC?YE?????@Yy????F?Mh?^qx??t? ?+??J????S?5A?!\,=!*?????Xs??O????j:??]???-;?>?¿)/????,??7???w?2?T??Z??V??;]?U?b?HxT ?\B???W? ????P_??Bq?:?}?P??QS?[\???S?62sz??;E}?????? ???e???-fe?t?^??f??0??vv@?? w?@/VU?T?C???? ?uk?r?,M?LB.8;\~"??p??/????gt8?q1?& ?c.KP??[S??1??K ??????D???????%~b???A`?qF?H?? ?(P"????1???\??w??G?_?!?\?_?+??P??????? ???W???7I?H$?^??d ^??1??T???>??S?/?D????Y?wS5(??+?? ???~?? ?p??Y?? ?B ?c=???''?L?????? t?^?????8 ??\?V??2`N?b??o]Y??T ?À=0??h?VA26 ?\??????8?jO??}?j_g??b??G?K.?`?1?{??40X?? }???P??83$y?md???>?? ??? endstream endobj 91 0 obj > stream H?LTkTSg???{A H.W_??>FD?0?(b@E ZTDH0B? yTT6?(??b%??"??V??)R?Nkm?v?U?5?Y?_V???????u????>8fk??8.]?j????7h?*??0]Z??+?e8?j??p???Q???? ?????28c?????s}?2r9M?,??y ???^?d?Yk??d?????????X???R???g??zU?$????T?? U?4E??e?"F?Wq?Bw? ?^?????U?D.U?S+??t]Vn?jA?J?Z?R????P?)4°~?v?&Y??iTz?wb8?a??b?)0?? ?f?~u?:9?8}?4*?-y???4u???/]?\????SJA?1???:??+???b> ?z? ????>?%E???kfk?*?d?.?d?_ct9ra?B?.u??;??}?;?{U???S?????f?[3?~0?D0 ?j??l?P?''E-??}f?!?|j?p??uh>??????B? ?!"`?r;??H: U?c???C4??? ??M?r~x7??.?$??{?????-4]??l?R=?@H???G??????zb?no?L?O@x?????4^?= ?\????f?sC?N??S7G?? ''? @??Y?"RRp??:`v(??M??n?m?5"????%?? ????Ij?q&?$"7?7.=???Z"K?f?T???C ?P ?8MY?Lg%''??D|???*?%?}????? "G?7!~????\? L????v???NX????/jgM???$5?????\z?W???????( ????cr+ ??{?3I_ G??F??#TU ;?J?} ???&A????????T?,??a????t???B??5???{?+9( q???/A6?!?S? ?X?!$q?1??.0?@???Z?"???b"?+?*?3P@??.,???pDpA~8r???k?''!?M?Y_? ?]BdN??x?j?9?k?6Q/?p?F?q?Hi??;?-O??C?(?^???R/?o?\0??I?^?cTb?? ??- ?J9??''?5??E~?P9t??????n?W`X "??D??q????z*/U?&4???e?a???!???[?m??????DZ?X?Z?_??=?>x???P?v????X?@?5M????:?8?|ttx ?3h&P??P?Bv?.b?-J??R?q?Md ?~:÷?:????]??? M? ???x)?%q???4?f>?IO}O?/]?6??`? ??-(? ?5?]?Jw!?h!?&?v??????Ü?5??`??c? ?8;a?\??.?v\?K?;?8??j?&???j2?? ;? ??-H?`?!#??$a??j??2??I>(O.?À???N???FR??f+ ?;q?b?A???!???,6''O??mA:\>?5????~?yK?k!?X??y??}????????t???CR?m?p???32+??_?????? ??;O?^u?t?|y??0??T,?????Pz ??????????bPz??`{??//?????:????K?p ???` ?qD?_"VTB??&)wf? }?C????-B?1?H,?H???Q?"R?z?????| QQ(9//5!z_?&)???i??????''?????U?5a?Q{@?4???j??XQq?qC??\G??@?tIV?????g??????v?-?:?y?????Tn>??Vs????Z_p??h\1??7X?%*??J?8P??4????"?y-r?W9 Z4!???D:??p????,86N2????1???kI2??v???????]?mV92xa?????????L??y?Lo??00??4U ??QVx?^gu?S@Qw??EW?8?R???$?e%??????a\??K:S?lR)??8?S?lv?????J???8TU?Xjk J???????,hb???2??K??Ce???9??+3Yl??U;???gk+??f???š~U??*????/?K?U??XQ???`?Z :?[}???? ???''6?p?#h? ?IeW??Xhk?6?{??n??=??,???S?|?(??)V*?? i?????j???n?k?????u??u???_????a{YgD%??? ?=??Ed?v?xl??)) ???vi?[9?7LIK??I?S; 3O?MS?]Z??????Gx??dGw??+?1??V?[C??)?s??P???)F??4??J?????5]g?3%????#??{???Y????A??7? ? ???????)}???????k???|??Ce#??)??k?J72p?L????;+`Jl?_"( W?J?:G??n?@?oa?)?I ??)??]%Œe:YM???e-^???m}z{???eBkj-?? ?I???l5?h ?l???3=??h??W?u25?H,?T+;s???8???w?c???? ?i?o?R? 0?n??fIB}???Z!?b?????f?;m?%2?a???[?99?_I_???h? ???K??7m?????hKp?????_{j???1??+/ ??M??????+j? O?6W???q???cuUP?8Q!Kh? Z?_?]??o6????X?????Tv?????(?s?x???b????T?}???;??y(,-??g ?y??X?? ?F`?''zeZzQv??? vO???1??(ó?s???~??n????h??????,B~? ??? ??A?Y?L???T?????,[ck1? ??~?>9G0?g?? ??(?TQ?À5icF\?Z?,g??(??q?e?h?39? U ??u??M?E?K-B1YhEWy !d?{?s/??????nõV??? _??s?A-?w??c?QwH??K???j?i? ?2F"?"?"?.?????9?a F6&??E''Y????v[?????(e? ??&?4?,???8???XF??????}$?w??X?~?y???^??QL?)M)?a??y?;??O?@?X?\i???8? s???????4[X%?^???2m?Pa????8????b ??;??[?x. j??G%C"?;?Jx,q??\??@a)y&?=5_9??Kh\r?*o{@?.?r??zF??? ?????r?\ie?@?ï???? j??8}?R?PY? ,????"????)?????k?"?8qo??T?soKC? ????]?#W y;?? 1h????*A ?{?m???Ÿ??*H?b\?|???5N#??jNRoo??;Q"?????BLO/???s( oY????,?????????,????w ;PQ? ???9??t???T??;?????Um?H??????XcT??Yswj??????H???r?????zC???3?X???l??>?3/?}#??D??I?sV?kv9dv????i.?1j??J? > endobj 93 0 obj > endobj 94 0 obj > /ExtGState > >> endobj 95 0 obj > endobj 96 0 obj > endobj 97 0 obj > stream x??YKo?H??W??a??Mf?L&?q& ''??`??@Q????T ?`?z???E???EVt8r?J|M1aRrqr?wA@I?Ir 2*?X???R??M?WSn???vb7/XV|?|??&??^????`(?9V?!??5_??x+??mF??????????? ??$$C??[?s{A\???S?-??B3''>`??I??~???6a >@?M*?? _??m?y???8??d2?????jV5?/%TJ?IJ?$?r??1??3? ??KSbU??Ms)ÉG fU6(|???*?(???q?_]?yP?Qy@?}FJ? ???.Q?"?/? ???b"??2?Es???"??Z)V ??_??I?(?4&7?????h??u?Ft?)?;k???x\,??#???Q5???j?= ???BòZ??!Rw?u?/?\b??,N?!& ?N?u]?h1?*??o?S?!,dFF@L|]?.??7?O??C7?kQ:??N}2?/???????[j??~z$??9?''*?x??J??? ] /Info 70 0 R /Size 98 /Root 72 0 R >> startxref 98802 %%EOF

Table of Contents

Preface and Acknowledgements.

1. Quality Standards.

1.1 What Quality is.

1.2 Mandatory and Voluntary Standards.

1.3 Pharmaceutical Industry Regulations.

1.4 US GXP Regulations.

1.5 European GXP Regulations.

1.6 Other GXP Regulations.

1.7 Good Manufacturing Practice - GMP.

1.8 Good Laboratory Practice - GLP.

1.9 Good Clinical Practice - GCP.

1.10 Medical Device Standards.

1.11 It Systems in The GXP And Medical Device Regulations.

1.12 GAMP.

1.13 Mandatory Quality Standards in Other Industries.

1.14 Legal Issues.

1.15 ISO.

1.16 ASTM.

1.17 IEEE.

1.18 TASKS.

2. Regulatory Requirements for IT Systems.

2.1 Introduction.

2.2 US Requirements.

2.3 EU Requirements.

2.4 21 CFR Part 11.

2.5 The "Part 11 Project".

2.6 EU GMP Annex 11.

2.7 PIC Document PI 011 Recommendation on Computerised Systems In Regulated "GXP" Environments.

2.8 GAMP.

2.9 ISO 9000-Series.

2.10 Comparison Between the Standards.

2.11 Conclusion.

2.12 Tasks.

3. IT Security.

3.1 Introduction.

3.2 Continuous Connections - Wireless Networks.

3.3 Threats.

3.4 Security Policy.

3.5 Tasks.

4. Quality Management Systems.

4.1 Introduction to QMS.

4.2 Definitions.

4.3 Principles for Quality Management.

4.4 Quality Management System Levels.

4.5 Creating a QMS.

4.6 Roles and Responsibilities.

4.7 Work Processes.

4.8 Controlled Documents.

4.9 Quality Policy--QP.

4.10 Quality Manual--QM.

4.11 Standard Operating Procedures.

4.12 The Art of Writing an SOP.

4.13 Tasks.

5. IT Integrated In the QMS in a User Organization.

5.1 Introduction.

5.2 How to Integrate the IT Systems in the QMS.

5.3 Generic Standard Operating Procedures (SOPS).

5.4 Procedures for Each System.

5.5 Tasks.

6. IT Integrated in the Supplier’s QMS.

6.1 Introduction.

6.2 Which Standards to Use?

6.3 Quality Management System.

6.4 System Development Models.

6.5 Documents for the Software Development.

6.6 Customer-Supplier Relationship.

6.7 Tasks.

7. Organization for an IT System.

7.1 Introduction.

7.2 Roles and Responsibilities for a Live System.

7.3 Groups in the IT System Organization.

7.4 Roles and Responsibilities for an IT Validation Project.

7.5 Outsourcing.

1.1 Service Level Agreement for Outsourcing.

7.6 Consultants.

8. The Legal Implications of an IT System.

8.1 Introduction.

8.2 Pharmaceutical Regulations.

8.3 Financial Systems.

8.4 Patent Systems.

8.5 Human Resource (HR) Systems.

8.6 Healthcare Systems.

8.7 Systems for Legal Information.

9. Advanced Quality Management Systems.

9.1 Introduction.

9.2 The Live QMS is a Good QMS.

9.3 Changes.

9.4 How to Keep the QMS Updated.

9.5 Training and Understanding.

9.6 How to Use A QMS Effectively As A Tool In The Organization - Not As a Straightjacket.

9.7 Tasks.

10. Audits.

10.1 Introduction.

10.2 ISO 9000 Series.

10.3 Tickit.

10.4 Why Audit?

10.5 Audit In A Risk-Based Environment.

10.6 Audit Scope.

10.7 Supplier Audit Preparations.

10.8 During the Audit.

10.9 What To Look For.

10.10 Other Issues.

10.11 Findings/Discrepancies.

10.12 Closing Meeting/Wash-Up Meeting.

10.13 Audit Report.

10.14 Conducting an Audit from the Receiving End Of The Table.

10.15 Tasks.

11. Validation of IT Systems.

11.1 Introduction.

11.2 External Requirements for Validation.

11.3 Internal Requirements for Validation.

11.4 Validation Cost.

11.5 Inspectors.

11.6 Validation Scope Is Changing.

11.7 Computer Validation Project.

11.8 Which Hardware and Software Shall Be Validated.

11.9 Network.

11.10 Software.

11.11 Risks and System Categories.

11.12 Qualifications.

11.13 DQ - Development Qualification.

11.14 IQ - Installation Qualification.

11.15 OQ - Operation Qualification.

11.16 PQ - Performance / Process Qualification.

11.17 Validation Master Plan VMP.

11.18 Validation Plan VP.

11.19 Validation Report.

11.20 Tasks.

12. Risk Assessment and Risk Management.

12.1 Introduction.

12.2 Addressing Risks.

12.3 Risk Assessment Tools.

12.4 Risk Assessment.

12.5 Risk Management.

12.6 Tasks.

13. Development Qualification.

13.1 Introduction.

13.2 User’s Point Of View.

13.3 Supplier’s Point of View.

13.4 Project: The New System in the User Organization.

13.5 The Four Assessments of System Selection.

13.6 Functional Specification and System Implementation.

13.7 Tasks.

14. Installation Qualification.

14.1 Introduction.

14.2 IQ Organizational Issues.

14.3 IQ Plan.

14.4 IQ Testing.

14.5 IQ Report.

14.6 Tasks.

15. Operational Qualification.

15.1 Introduction.

15.2 OQ Framework.

15.3 What If The Supplier Has Done OQ?

15.4 OQ Plan.

15.5 OQ Testing.

15.6 Documentation of the Testing.

15.7 OQ Report.

15.8 Tasks.

16. Process/Performance Qualification.

16.1 Introduction.

16.2 PQ Plan.

16.3 PQ Test Plans.

16.4 Documentation During the Testing.

16.5 PQ Report.

16.6 Ongoing PQ.

16.7 Tasks.

17. Laboratory Instrument Systems.

17.1 Introduction.

17.2 Instruments.

17.3 Analytical Instruments in the Laboratory.

17.4 Raw Data and Meta Data.

17.5 Devices.

17.6 Biometric Devices.

17.7 Electronic Lab Notebooks ELN.

17.8 Validation of Computerized Instrument Systems.

17.9 Pure Computer Systems.

17.10 Computerized Instruments That Can Run ‘Barefoot’.

17.11 Integrated Computerized Instruments.

17.12 Qualification of Laboratory Instruments.

18. Laboratory Information Management Systems.

18.1 Introduction.

18.2 Build or Buy a New LIMS?

18.3 The Real Cost Of LIMS.

18.4 Differences Between Commercial LIMS Systems.

18.5 Static and Dynamic Data.

18.6 Static Data.

18.7 Dynamic Data.

18.8 LIMS Functionality.

18.9 Types of Production.

18.10 Analytical Methods.

18.11 Calculations in Analytical Methods.

18.12 Specifications and Limits.

18.13 Standards, Solutions and Chemicals Used In the Lab.

18.14 Instrument Connections and Definitions.

18.15 Instrument Information.

18.16 Do We Store The Data In The Instrument System Or In LIMS?

18.17 Stability Studies and Stability Testing.

18.18 Pharmacokinetic Studies and Testing.

18.19 Dissolution Testing.

18.20 Patients/Animals Information.

18.21 Customer Information.

18.22 Bar Coded Labels.

18.23 RFID.

18.24 Chain of Custody.

18.25 Sample Scheduling and Workload.

18.26 Status.

18.27 Security.

18.28 Specifying and Choosing the New LIMS.

18.29 Trace Matrix.

18.30 List of Sops for a LIMS.

18.31 Tasks.

18.32 Further Reading.

19. Building Management System (BMS) and Heating, Ventilation, Air Conditioning.

19.1 Introduction.

19.2 BMS Systems.

19.3 PLC.

19.4 SCADA.

19.5 Control Parameters and Instrumentation.

19.6 Sterile Facilities.

19.7 Regulatory Requirements and Validation Enforcement.

19.8 Validation of Old HVAC / BMS Systems.

19.9 New Systems.

19.10 Risk Assessment.

19.11 Electronic Records in the BMS.

19.12 Validation.

19.13 IQ.

19.14 OQ/PQ.

19.15 Standard Operating Procedures.

19.16 Tasks.

Appendix 1 Regulation comparisons.

Appendix 2 Terminology.

Index.