{"id":6689,"date":"2018-04-10T12:33:15","date_gmt":"2018-04-10T10:33:15","guid":{"rendered":"https:\/\/fedegari.com\/fedegari-receives-fda-inspectors\/"},"modified":"2019-10-11T14:43:16","modified_gmt":"2019-10-11T12:43:16","slug":"fedegari-receives-fda-inspectors","status":"publish","type":"post","link":"https:\/\/fedegari.com\/de\/fedegari-receives-fda-inspectors\/","title":{"rendered":"FEDEGARI EMPF\u00c4NGT FDA-INSPEKTOREN …"},"content":{"rendered":"

[vc_row full_width=“stretch_row_content_no_spaces“ equal_height=“yes“ content_placement=“middle“ css=“.vc_custom_1551448839631{background-color: #eaedf2 !important;}“][vc_column width=“1\/2″ css=“.vc_custom_1554287557430{background-image: url(https:\/\/fedegari.com\/wp-content\/uploads\/2019\/04\/news8b.jpg?id=2461) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}“ offset=“vc_hidden-xs“][\/vc_column][vc_column width=“1\/2″][vc_row_inner css=“.vc_custom_1551447616941{padding-right: 30px !important;padding-left: 30px !important;}“][vc_column_inner width=“1\/6″][\/vc_column_inner][vc_column_inner width=“2\/3″][vc_empty_space height=“60px“][vc_column_text]<\/p>\n

HOME <\/i><\/b><\/span><\/span>\u00a0NEWS<\/span><\/b><\/span><\/p>\n

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FEDEGARI EMPF\u00c4NGT FDA-INSPEKTOREN F\u00dcR EINE SCHULUNG ZUR CHEMISCHEN BIO-DEKONTAMINATION<\/strong><\/h1>\n

[\/vc_column_text][vc_empty_space height=“45px“][vc_column_text css_animation=“fadeIn“]Das Fedegari US Tech Center f\u00fchrte Schulungen zu chemische Bio-Dekontaminationen f\u00fcr FDA-Inspektoren durch.<\/p>\n

Es war eine gro\u00dfe Freude, die Inspektoren der FDA (Food and Drugs Administration<\/a>) f\u00fcr ein Seminar zum Thema „Chemische Bio-Dekontamination<\/a> mit Wasserstoffperoxid“ im vergangenen M\u00e4rz im Fedegari Tech Center<\/a> in Sellersville (Philadelphia, USA) zu empfangen.[\/vc_column_text][vc_empty_space height=“60px“][\/vc_column_inner][vc_column_inner width=“1\/6″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner offset=“vc_hidden-lg vc_hidden-md vc_hidden-sm“][vc_single_image image=“2240″ img_size=“full“][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=“20px“][\/vc_column][\/vc_row][vc_row full_width=“stretch_row“ equal_height=“yes“ css=“.vc_custom_1551448777969{margin-top: 60px !important;margin-bottom: 60px !important;}“ el_id=“content“][vc_column width=“1\/2″][vc_column_text css_animation=“fadeIn“]Das Fedegari Training & Education Team (vertreten durch Serena Ambrosini und Maria Luisa Bernuzzi) war stolz darauf, mit Jim Agalloco<\/a>, dem international anerkannten Experten f\u00fcr aseptische Produktion, und Mesa Labs<\/a> zusammenzuarbeiten, um Erfahrungen \u00fcber Prozesse und Anwendungen auszutauschen.<\/p>\n

Das eint\u00e4gige Training mit dem Titel „INSIGHTS IN CHEMICAL BIO-DECONTAMINATION: Design, Applications and Validation of H2O2 Processes“ wurde speziell f\u00fcr die amerikanischen FDA-Inspektoren entwickelt.<\/p>\n

W\u00e4hrend des Trainings konnten die FDA-Inspektoren mehr \u00fcber die Prozessentwicklung erfahren und hatten die M\u00f6glichkeit, die Technologie von Fedegari-Systemen und Bio-Dekontaminationsanlagen (FCDV) kennenzulernen. Dar\u00fcber hinaus konnte das Team die Verwendung von biologischen Indikatoren und den Fedegari BI Evaluation Resistometer (BIER) besser verstehen lernen.[\/vc_column_text][vc_empty_space][vc_single_image image=“6690″ img_size=“full“][\/vc_column][vc_column width=“1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=“60px“][\/vc_column_inner][\/vc_row_inner][vc_column_text]Es war eine gro\u00dfartige Gelegenheit, Ideen und Fallstudien zwischen Fedegari, FDA und Mesa Labs auszutauschen.<\/p>\n

Jim Agalloco<\/a> ist Fedegaris langj\u00e4hriger Partner und Senior Advisor.<\/p>\n

Das Schulungsprogramm:<\/strong><\/p>\n

INSIGHTS IN CHEMICAL BIO-DECONTAMINATION (EINBLICKE IN DIE CHEMISCHE BIO-DEKONTAMINATION): Design, applications and validation of H2O2 processes (Design, Anwendungen und Validierung von H2O2-Prozessen)<\/em><\/p>\n

Prozesse mit verdampftem H2O2 (J. Agalloco)<\/em>
\nProzessbeschreibung und Herausforderungen<\/em><\/p>\n

Biologische Indikatoren (K. McCauley)<\/em><\/p>\n

Prozessentwicklung und PQ (J. Agalloco)<\/em>
\nValidierungsma\u00dfnahmen<\/em><\/p>\n

BI Evaluation Resistometer (M. L. Bernuzzi)<\/em>
\nFedegari Prototyp<\/em><\/p>\n

Fedegari-Systemvorf\u00fchrung (S. Ambrosini)<\/em>
\nKonstruktionsmerkmale<\/em>
\nLadungs- und Prozessbeispiele<\/em><\/p>\n

Prozessmeilensteine (M. L. Bernuzzi)<\/em>
\nSteuerung, Reproduzierbarkeit, Robustheit, Sicherheit<\/em>[\/vc_column_text][vc_empty_space][vc_single_image image=“6696″ img_size=“full“][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=“60px“][\/vc_column][\/vc_row][vc_row full_width=“stretch_row“ equal_height=“yes“ css=“.vc_custom_1551450117939{background-color: #eaedf2 !important;}“][vc_column][vc_row_inner css=“.vc_custom_1552902064695{background-color: #c4161c !important;}“][vc_column_inner][vc_empty_space height=“20px“][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

Das Fedegari US Tech Center f\u00fchrte Schulungen zu chemische …<\/p>\n","protected":false},"author":1,"featured_media":6691,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[231],"tags":[308,243],"class_list":["post-6689","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en-ru-de","tag-308","tag-news-en-de"],"yoast_head":"\nFEDEGARI EMPF\u00c4NGT FDA-INSPEKTOREN ... - Fedegari - Solutions for Sterile Drug Manufacturing<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fedegari.com\/en\/fedegari-receives-fda-inspectors\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FEDEGARI EMPF\u00c4NGT FDA-INSPEKTOREN ... - Fedegari - Solutions for Sterile Drug Manufacturing\" \/>\n<meta property=\"og:description\" content=\"Das Fedegari US Tech Center f\u00fchrte Schulungen zu chemische ...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fedegari.com\/en\/fedegari-receives-fda-inspectors\/\" \/>\n<meta property=\"og:site_name\" content=\"Fedegari - 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