{"id":1214,"date":"2023-02-25T08:05:04","date_gmt":"2023-02-25T07:05:04","guid":{"rendered":"https:\/\/bioeducator.eu\/?page_id=1214"},"modified":"2025-03-14T00:57:43","modified_gmt":"2025-03-13T23:57:43","slug":"szkolenie-zarzadzanie-ryzykiem-jakosci","status":"publish","type":"page","link":"https:\/\/bioeducator.eu\/?page_id=1214","title":{"rendered":"Szkolenie &#8222;Zarz\u0105dzanie ryzykiem jako\u015bci&#8221;"},"content":{"rendered":"\n<div class=\"wp-block-media-text alignwide has-media-on-the-right is-stacked-on-mobile is-image-fill-element\" style=\"grid-template-columns:auto 45%\"><div class=\"wp-block-media-text__content\">\n<p class=\"wp-block-paragraph\">We wspo\u0142czesnym \u015bwiecei rozw\u00f3j i produkcja lek\u00f3w, czy to tradycyjnych czy biologicznych, oparta jest o regu\u0142y projektowania jako\u015bci. ICH, FDA i EMA od wielu lat pracuj\u0105 nad implementacj\u0105 odpowiednich rozwi\u0105za\u0144. Jednym z kluczowych aspekt\u00f3w projektowania jako\u015bci jest zarz\u0105dzanie ryzykiem. Regulatorzy jasno okre\u015blaj\u0105 zasady zarz\u0105dzania ryzykiem a tak\u017ce wskazuj\u0105 pefereowane narz\u0119dzia, kt\u00f3re nale\u017cy stosowa\u0107.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>W trakcie dwudniowych warsztat<\/strong>\u00f3w uczestnicy poznaj\u0105 podstawy zarz\u0105dzania ryzykiem i w praktyczny spos\u00f3b zapoznaj\u0105 si\u0119 z prowadzeniem analizy ryzyka r\u00f3\u017cnymi technikami.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Dla kogo?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Pracownicy zarz\u0105dzania jako\u015bci\u0105, produkcji, dzia\u0142\u00f3w badawczo-rozwojowych, MSAT, RA bior\u0105cy udzia\u0142 w procesach analizy i mitygacji ryzyka.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zakres szkolenia<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Co to jest ryzyko?<\/li>\n\n\n\n<li>Om\u00f3wienie ICH Q9 &#8211; Zarz\u0105dzanie ryzykiem jako\u015bci<\/li>\n\n\n\n<li>Proces analizy ryzyka<\/li>\n\n\n\n<li>Jak stworzy\u0107 dobry zesp\u00f3\u0142 roboczy?<\/li>\n\n\n\n<li>Techniki analizy ryzyka\n<ul class=\"wp-block-list\">\n<li>PHA<\/li>\n\n\n\n<li>RRF<\/li>\n\n\n\n<li>FMEA<\/li>\n\n\n\n<li>FTA<\/li>\n\n\n\n<li>HAZOP i HACCP<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Narz\u0119dzia wspomagaj\u0105ce analiz\u0119 ryzyka\n\n\n\n\n\n\n\n\n\n\n<ul class=\"wp-block-list\">\n<li>Schemat blokowy<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Karty kontrolne<\/li>\n\n\n\n<li>Karty kontrole Shewart&#8217;a<\/li>\n\n\n\n<li>Zdolno\u015b\u0107 procesu<\/li>\n\n\n\n<li>Wykres sum skumulowanych<\/li>\n\n\n\n<li>Wykres Ishikava<\/li>\n\n\n\n<li>Wykres Pareto<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Dost\u0119pne daty<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Aktualnie brak termin\u00f3w<\/li>\n<\/ul>\n<\/div><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"612\" height=\"408\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2022\/03\/istockphoto-868668738-612x612-1.jpg\" alt=\"Komora laminarna klasy II, BSL-2, 2 klasa bezpiecze\u0144stwa biologicznego\" class=\"wp-image-548 size-full\" style=\"object-position:50% 50%\" srcset=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2022\/03\/istockphoto-868668738-612x612-1.jpg 612w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2022\/03\/istockphoto-868668738-612x612-1-300x200.jpg 300w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2022\/03\/istockphoto-868668738-612x612-1-391x260.jpg 391w\" sizes=\"auto, (max-width: 612px) 100vw, 612px\" \/><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/bioeducator.eu\/?page_id=103\">Powr\u00f3t do szkole\u0144<\/a><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Nadchodz\u0105ce szkolenia<\/h2>\n\n\n\n<div class=\"mec-wrap mec-skin-carousel-container \" id=\"mec_skin_295\">\r\n        <div class=\"mec-skin-carousel-events-container\" id=\"mec_skin_events_295\">\r\n        <div class=\"mec-wrap \">\r\n    <div class=\"mec-event-carousel-type1\">\r\n                <div class='mec-owl-crousel-skin-type1 mec-owl-carousel mec-owl-theme'>\r\n                        <article class=\"mec-event-article  mec-clear \" itemscope>\r\n                                        <div class=\"event-carousel-type1-head clearfix\">\r\n                    <div class=\"mec-event-date mec-color\">\r\n                        <div class=\"mec-event-image\">\r\n                            <a   data-event-id=\"1774\" href=\"https:\/\/bioeducator.eu\/?page_id=1017\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"474\" height=\"324\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/02\/teachers-5499190_1920-edited-474x324.jpg\" class=\"attachment-meccarouselthumb size-meccarouselthumb wp-post-image\" alt=\"Analytical Method Lifecycle\" data-mec-postid=\"1774\" \/><\/a>                                                    <\/div>\r\n                        <div class=\"mec-event-date-carousel\">\r\n                            <span class=\"mec-start-date-label\" itemprop=\"startDate\">08<\/span>                            <div class=\"mec-event-date-info\"><span class=\"mec-start-date-label\" itemprop=\"startDate\">czerwiec<\/span><\/div>\r\n                            <div class=\"mec-event-date-info-year\">2026<\/div>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"mec-event-carousel-content\">\r\n                                        <h4 class=\"mec-event-carousel-title\"><a class=\"mec-color-hover\"  data-event-id=\"1774\" href=\"https:\/\/bioeducator.eu\/?page_id=1017\" target=\"_blank\" rel=\"noopener\">Walidacja metod analitycznych<\/a><\/h4>\r\n                                        <p class=\"mec-carousel-event-location\"><span><\/p>\r\n                                                        <\/div>\r\n                            <\/article>\r\n                                    <article class=\"mec-event-article  mec-clear \" itemscope>\r\n                                        <div class=\"event-carousel-type1-head clearfix\">\r\n                    <div class=\"mec-event-date mec-color\">\r\n                        <div class=\"mec-event-image\">\r\n                            <a   data-event-id=\"1796\" href=\"https:\/\/bioeducator.eu\/?page_id=1791\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"474\" height=\"324\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/02\/louis-reed-pwcKF7L4-no-unsplash-edited-474x324.jpg\" class=\"attachment-meccarouselthumb size-meccarouselthumb wp-post-image\" alt=\"testy cytotoksyczno\u015bci\" data-mec-postid=\"1796\" \/><\/a>                                                    <\/div>\r\n                        <div class=\"mec-event-date-carousel\">\r\n                            <span class=\"mec-start-date-label\" itemprop=\"startDate\">15<\/span>                            <div class=\"mec-event-date-info\"><span class=\"mec-start-date-label\" itemprop=\"startDate\">czerwiec<\/span><\/div>\r\n                            <div class=\"mec-event-date-info-year\">2026<\/div>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"mec-event-carousel-content\">\r\n                                        <h4 class=\"mec-event-carousel-title\"><a class=\"mec-color-hover\"  data-event-id=\"1796\" href=\"https:\/\/bioeducator.eu\/?page_id=1791\" target=\"_blank\" rel=\"noopener\">Walidacja metod bioanalitycznych<\/a><\/h4>\r\n                                        <p class=\"mec-carousel-event-location\"><span><\/p>\r\n                                                        <\/div>\r\n                            <\/article>\r\n                                    <article class=\"mec-event-article mec-multiple-event mec-clear \" itemscope>\r\n                                        <div class=\"event-carousel-type1-head clearfix\">\r\n                    <div class=\"mec-event-date mec-color\">\r\n                        <div class=\"mec-event-image\">\r\n                            <a   data-event-id=\"2036\" href=\"https:\/\/bioeducator.eu\/?page_id=481\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"474\" height=\"324\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/02\/lukas-blazek-mcSDtbWXUZU-unsplash-edited-474x324.jpg\" class=\"attachment-meccarouselthumb size-meccarouselthumb wp-post-image\" alt=\"walidacja arkuszy obliczeniowych\" data-mec-postid=\"2036\" \/><\/a>                                                    <\/div>\r\n                        <div class=\"mec-event-date-carousel\">\r\n                            <span class=\"mec-start-date-label\" itemprop=\"startDate\">22 - 23<\/span>                            <div class=\"mec-event-date-info\"><span class=\"mec-start-date-label\" itemprop=\"startDate\">czerwiec<\/span><\/div>\r\n                            <div class=\"mec-event-date-info-year\">2026<\/div>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"mec-event-carousel-content\">\r\n                                        <h4 class=\"mec-event-carousel-title\"><a class=\"mec-color-hover\"  data-event-id=\"2036\" href=\"https:\/\/bioeducator.eu\/?page_id=481\" target=\"_blank\" rel=\"noopener\">Szkolenie online: Walidacja arkuszy obliczeniowych<\/a><\/h4>\r\n                                        <p class=\"mec-carousel-event-location\"><span><\/p>\r\n                                                        <\/div>\r\n                            <\/article>\r\n                                    <article class=\"mec-event-article  mec-clear \" itemscope>\r\n                                        <div class=\"event-carousel-type1-head clearfix\">\r\n                    <div class=\"mec-event-date mec-color\">\r\n                        <div class=\"mec-event-image\">\r\n                            <a   data-event-id=\"2231\" href=\"https:\/\/bioeducator.eu\/?page_id=1380\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"474\" height=\"324\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2022\/01\/national-cancer-institute-fd0b-Bl4cFc-unsplash-474x324.jpg\" class=\"attachment-meccarouselthumb size-meccarouselthumb wp-post-image\" alt=\"\" data-mec-postid=\"2231\" \/><\/a>                                                    <\/div>\r\n                        <div class=\"mec-event-date-carousel\">\r\n                            <span class=\"mec-start-date-label\" itemprop=\"startDate\">29<\/span>                            <div class=\"mec-event-date-info\"><span class=\"mec-start-date-label\" itemprop=\"startDate\">czerwiec<\/span><\/div>\r\n                            <div class=\"mec-event-date-info-year\">2026<\/div>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"mec-event-carousel-content\">\r\n                                        <h4 class=\"mec-event-carousel-title\"><a class=\"mec-color-hover\"  data-event-id=\"2231\" href=\"https:\/\/bioeducator.eu\/?page_id=1380\" target=\"_blank\" rel=\"noopener\">Transfer metod analitycznych<\/a><\/h4>\r\n                                        <p class=\"mec-carousel-event-location\"><span><\/p>\r\n                                                        <\/div>\r\n                            <\/article>\r\n                                <\/div>\r\n        \t<\/div>\r\n<\/div>    <\/div>\r\n    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nadchodz\u0105ce szkolenia<\/p>\n","protected":false},"author":1,"featured_media":548,"parent":103,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","footnotes":""},"class_list":["post-1214","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Szkolenie 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