{"id":195,"date":"2015-07-02T21:07:15","date_gmt":"2015-07-02T19:07:15","guid":{"rendered":"https:\/\/bloggcp.wordpress.com\/?page_id=195"},"modified":"2020-10-25T21:35:44","modified_gmt":"2020-10-25T21:35:44","slug":"ciekawostki","status":"publish","type":"page","link":"https:\/\/bloggcp.pl\/index.php\/ciekawostki\/","title":{"rendered":"Ciekawostki"},"content":{"rendered":"<ul>\n<li>FDA &#8211; List ostrzegawczy dla francuskiego Badacza<\/li>\n<li>\n<h5><a href=\"http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/2015\/ucm452031.htm\" target=\"_blank\" rel=\"noopener noreferrer\">FDA issued Warrning Letter for French Investigator&nbsp;<\/a><\/h5>\n<\/li>\n<\/ul>\n<p>Obserwacje raczej mo\u017cna nazwa\u0107 standardowymi:<\/p>\n<ol>\n<li>Nieprzestrzeganie protoko\u0142u.<\/li>\n<li>Niewykonane badania laboratoryjne.<\/li>\n<li>Brak zg\u0142osze\u0144 SAE<\/li>\n<\/ol>\n<p>FDA skrytykowa\u0142o odpowied\u017a badacza na formularz&nbsp;FDA 483 , kt\u00f3ry w trakcie inspekcji zostawili w o\u015brodku inspektorzy. Formularz zawiera\u0142 wyliczone nieprawid\u0142owo\u015bci i odst\u0119pstwa od CFR (Code of Federal Regulations). Wed\u0142ug FDA odpowied\u017a Badacza nie zawiera\u0142a wystarczaj\u0105cej analizy przyczyn (root cause) i opisu dzia\u0142a\u0144 zapobiegaj\u0105cych.<\/p>\n<p>Z\u0142o\u015bliwie dodam, \u017ce nie dziwi mnie to, \u017ce spotka\u0142o to francuskiego badacza. :)))) &nbsp;Powinien si\u0119 czu\u0107 wyr\u00f3\u017cniony bo FDA ekstremalnie rzadzko pisze taki ostrzegajacy list do badacza z poza Stan\u00f3w Zjednoczonych.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA &#8211; List ostrzegawczy dla francuskiego Badacza FDA issued Warrning Letter for French Investigator&nbsp; Obserwacje raczej mo\u017cna nazwa\u0107 standardowymi: Nieprzestrzeganie protoko\u0142u. Niewykonane badania laboratoryjne. Brak zg\u0142osze\u0144 SAE FDA skrytykowa\u0142o odpowied\u017a badacza na formularz&nbsp;FDA 483 , kt\u00f3ry w trakcie inspekcji zostawili w o\u015brodku inspektorzy. Formularz zawiera\u0142 wyliczone nieprawid\u0142owo\u015bci i odst\u0119pstwa od [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":197,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"footnotes":""},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ciekawostki - KOSIERADZKI.com<\/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:\/\/bloggcp.pl\/index.php\/ciekawostki\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ciekawostki - KOSIERADZKI.com\" \/>\n<meta property=\"og:description\" content=\"FDA &#8211; List ostrzegawczy dla francuskiego Badacza FDA issued Warrning Letter for French Investigator&nbsp; Obserwacje raczej mo\u017cna nazwa\u0107 standardowymi: Nieprzestrzeganie protoko\u0142u. 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