Dr. Dennis Sandkühler publishes technical articles in in the “GMP compliance adviser” (German: “GMP-Berater”) as well as the German GMP magazine “GMP-Magazin Logbook”

News article: Dr. Dennis Sandkühler publishes technical article in

A team of ex­perts con­sis­ting of Dr. Den­nis Sand­küh­ler, Mar­kus Roemer and Dr. Sieg­fried Schmitt has suc­cess­ful­ly pu­blis­hed an ar­ti­cle en­ti­t­led “9.D Sys­tem Clas­si­fi­ca­ti­on and Risk Ma­nage­ment” (Ger­man: “9.D Sys­tem­klas­si­fi­zie­rung und Ri­si­ko­ma­nage­ment”) in the “GMP com­pli­an­ce ad­vi­ser” of the GMP pu­bli­shing house Peither.

In it, you will find an­s­wers to the fol­lowing ques­ti­ons, among others:

  • What cri­te­ria can be used to clas­si­fy com­pu­ter systems?
  • What are the ISPE GAMP®5 categories?
  • What is the role of risk ma­nage­ment in the va­li­da­ti­on of com­pu­te­ri­zed systems?
  • What are the spe­cial fea­tures to be con­si­de­red in the risk as­sess­ment of com­pu­ter-ba­sed systems?

Fur­ther­mo­re, our col­league Dr. Den­nis Sand­küh­ler again suc­cee­ded in pla­cing an edi­to­ri­al with the GMP pu­blis­her Peit­her with his se­cond tech­ni­cal ar­ti­cle “9.B Re­qui­re­ments of the AMWHV for com­pu­te­ri­zed sys­tems” (Ger­man: “9.B An­for­de­run­gen der AMWHV für com­pu­ter­ge­stütz­te Sys­te­me”). In this ar­ti­cle you will learn more about the re­qui­re­ments of the re­gu­la­ti­ons for com­pu­ter-ba­sed sys­tems and their va­li­da­ti­on. In ad­di­ti­on, the ap­p­li­ca­ble re­gu­la­to­ry re­qui­re­ments for com­pu­te­ri­zed sys­tems and com­pu­ter sys­tem va­li­da­ti­on in Ger­ma­ny, Eu­ro­pe and the USA are analyzed.

Re­cent­ly, Dr. Do­ris Bor­chert (edi­tor) was able to wri­te an in­te­res­ting ar­ti­cle for the Ger­man GMP ma­ga­zi­ne “Log­buch” tog­e­ther with Dr. Den­nis Sand­küh­ler. Un­der the tit­le Ri­si­ko­be­ur­tei­lung com­pu­ter­ge­stütz­ter Sys­te­me” (Eng­lish: “Risk as­sess­ment of com­pu­ter-ba­sed sys­tems”) you will gain ex­ci­ting in­sights around the risk as­sess­ment and eva­lua­ti­on of com­pu­ter-ba­sed systems.

The GMP com­pli­an­ce ad­vi­ser
The GMP com­pli­an­ce ad­vi­ser is the world’s lar­gest stan­dard re­fe­rence for qua­li­ty ma­nage­ment in the phar­maceu­ti­cal in­dus­try. It com­bi­nes on­go­ing up­dates of glo­bal re­gu­la­ti­ons with re­com­men­da­ti­ons from ex­perts in the field. This me­ans that the world’s lar­gest GMP know­ledge por­tal is at your side when im­ple­men­ting Good Ma­nu­fac­tu­ring Practice.

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