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‘swiarre020 ‘Audling Process Validation & Developing Protocols BONEZONE Auditing Process Validation & Developing Protocols Ponti aC gare | nay 15,214 orn ‘a en nde wet endcang Continue learning from Rob Packard at OMTEC 2014 ave you oven perm eros vlaton prota far now pace of equpmentor ecqured a prooss al Wasnt Pepe vale? at, corer youll Hever, you can be aan hal hres a marfatsing engineer ow cules away who lls nighare abouts exzeora. ely, ne ‘mp: parchanes nse ne pronase on eqn walston eri rom the manarirer—probabl ma pense pre fhausangs ola, Un, the aon ‘amples ea waste f money anh esutn fecssvalaton snedequt, ‘ating process valton is ae pporunty for using the pocess approach oeuting Du mest asus Us @ hacks Tpleay, 56 lame queso ke 2-Have yo made ey ranges the proses? 3. Have you moved ie pment? Frat al ao hsoquosons canbe ansnred wh ayo resporse, Even me mos exseranoad aude net kayo espana mt aytng other en tba wordy you ate ‘competent autor you wil ak or records, Fr example «ypc comple aud checks. Regutaton Whatio Look st Wate Look tor Nowe 120.6- procoss | vaidaton Protos 1o100G er | cominea 1100 (P1251) was promed athe ure of maasn and vee sister ara Report suortas equpment Palas (Pv-123-2 wot permed st enamine! ope Stig wo Process wax menus and | Changes inthe evan nity for the [No pocee changes ee indcaldn te workineuctonreven nino oaumerss mR) 0700- amerance reas Leeson tegument annonins | The equpments he sme ocaon at «eno nthe vabten reson. a0 Deve Hey Record DUR) [Actual operating ange od Feria a ear ws so 00F fre 12. Ti the nornalirpace retucion cori eesti te OM, ‘une singe o eoserars ne vrs inp ar opus fhe vain proces, The os ile agra mont Wx ke me foie blow (she ea years acl on ‘eon Lin Austin with What Equipment Facltie & Materials? whe? 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This mparta, because valald enuprart dot at lays fala way Baten be aly ceca ie ree ic a alia sepey. you sre Insiaing new egepmant sr mewngequpment eh pparunty lo rove your rovnur alaion ettce Hthe prove vlaton maths were net igor, reve secant ofthis rice cretly ans 28d ecg ne GH quence eocument YoU maha cans having a vakstor exer even your IIOGIPA peas bles npleaatn ‘Robert Pacard a regulatory consutnt with 20 years of experince Inthe medical device, pharmaceutical and bloechnology Indies, Robert served in seior ‘managements several masa device companies, inching Presiset ana CEO ofa eparescople maging company His Guay Management System expertise covrs all largest Noted Bodies, Roberts special Is egusor submissions for highs medial devies, such a implants and drugisevice combination product for CE Marking ‘pplication, Canadian medial device applications and S10) eubmlasion. The met fverte pr oth Jo ering thar He canbe reached at rob 240cer com. hitpssiwwwbonezonepub.comi22-supply-chain-management/896-aueling-process-valdation-a-developing protocols?implzcomponent&prnt=18page= 2/3 ‘wiarra020 ‘Audling Process Validation & Developing Protocols ag" nage Rand, Sate 18 i Reahs Reserves (Chagin ate, Oma 4028 USA Ste Maraaed 3 one 40 S43 08 Fe a 59.2122 ‘Spon Protes oa Group hitpssiwww-bonezonepub.com/22-supply-chain-management896-aueling-process-valdation-2-developing protocols impl=component&print

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