{"id":19828,"date":"2024-05-30T15:13:42","date_gmt":"2024-05-30T15:13:42","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/?p=19828"},"modified":"2024-05-30T15:13:42","modified_gmt":"2024-05-30T15:13:42","slug":"63rd-afi-symposium-gian-paolo-baranzonis-interview","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/afi-interview\/63rd-afi-symposium-gian-paolo-baranzonis-interview\/","title":{"rendered":"63rd AFI Symposium \u2013 Gian Paolo Baranzoni\u2019s interview"},"content":{"rendered":"<p><span lang=\"en-US\"><strong>The new GAMP 5<\/strong> guidelines, introduced 14 years after the previous version, bring many significant updates. They reflect an updated technological context, vastly different from that of 2008, <\/span><span lang=\"en-US\">substantially a geological era has passed<\/span><span lang=\"en-US\">. <\/span><\/p>\n<p><span lang=\"en-US\">Most notably, <strong>they represent a shift in approach,<\/strong> <strong>with explicit references to ISO standards <\/strong><\/span><span lang=\"en-US\">as for ISO 9000 and ISO 9001 and the link between them and tha GMP standards demonstrating an approach to the Quality extended to the entire company. <\/span><\/p>\n<p><span lang=\"en-US\">Furthermore, a very important aspect <\/span><span lang=\"en-US\">for tha ICT field <\/span><span lang=\"en-US\">is <\/span><span lang=\"en-US\"><strong>the integration of the ITIL framework<\/strong> for more effective IT service governance. <strong>Cybersecurity is emphasized,<\/strong> with the adoption of advanced standards such a<strong>s ISO 27001 and the NIST framework,<\/strong> in response to the new European directive on cybersecurity (NIS2), along with a DevSecOps approach that requires close collaboration between development, security, and operations.<\/span><\/p>\n<p lang=\"en-US\">However,<strong> practical implementation is not without challenges<\/strong>, starting with the necessary change in perspective: all parties involved in technology must support ICT compliance.<\/p>\n<p lang=\"en-US\">This can be <strong>complex, both in terms of involving everyone and fostering collaboration among different parts of the company.<\/strong> Additionally, managing cybersecurity must be seen as a continuous and systemic process, rather than a series of one-time interventions.<\/p>\n<p lang=\"en-US\">These and many other aspects of the new GAMP 5 introduction will be addressed in the<strong> XVII session of the AFI Symposium<\/strong>\u00a0 and have been discussed by<strong> Gian Paolo Baranzon<\/strong>i. of the Techonlogical Innovation Study Group of AFI in this interview.<\/p>\n<p>&nbsp;<\/p>\n<p><iframe loading=\"lazy\" title=\"63\u00b0 Simposio AFI_Intervista a Gian Paolo Baranzoni\" width=\"696\" height=\"392\" src=\"https:\/\/www.youtube.com\/embed\/VzVxirqxRRw?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The new GAMP 5 guidelines bring many significant updates but also important challenges to put into practice.<\/p>\n","protected":false},"author":4,"featured_media":19829,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[1065],"tags":[1071,1070],"class_list":{"0":"post-19828","1":"post","2":"type-post","3":"status-publish","4":"format-video","5":"has-post-thumbnail","7":"category-afi-interview","8":"tag-cybersecurity-en","9":"tag-gamp5","10":"post_format-post-format-video"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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