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CLASS:PUBLIC
DTSTART;TZID=Asia/Kolkata:20250310T090000
DTEND;TZID=Asia/Kolkata:20250312T140000
DTSTAMP:20241202T062300
UID:MEC-2b0aa0d9e30ea3a55fc271ced8364536@biiworld.com
CREATED:20241202
LAST-MODIFIED:20241202
PRIORITY:5
TRANSP:OPAQUE
SUMMARY:GXP – Good Practices
DESCRIPTION:\nIn-person Course Delivery – Live Training Sessions\nAttendance for 3 Days Training\nGuided Learning Hours – 12\nCase Studies, Exercises, Q & A,\nPre-Course Access: Pre-Event Questionnaire, Presentation Slide Deck\n\nCourse Overview\nThis 12 hrs online expert course covers GXP aspects for Computer System Validation (CSV) and Data Integrity (DI). The 3 Day sessions also cover the baseline for digitalization projects, digital validation, qualification of cloud computing used in the GXP environment. It contains a full session about the validation of artificial intelligence (AI), deep learning and machine learning (ML).\nAll applicable world-wide regulations will be introduced, including but not limited to EU GMP Annex 11 and US-FDA 21 CFR Part 11 – ERES and others. Learn about the background, effects and details regarding the current changes and extensions of the ISPE GAMP®5 – Second Edition – which was released in August 2022.\nTrainer’s Profile\nMarkus Roemer is an independent consultant, involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.\nMarkus Roemer is a frequently invited speaker and trainer by organizations such as PTS (pharmaceutical training services), ISPE, European Compliance Academy and the European QP Association at more than 100 events or training. In his current position as Managing Director at comes compliance services he oversees consultancy services for IT and PQS\ncompliance. Mr. Roemer has written widely about computer system validation and the use of electronic systems (eDMS, EBR, ERP) and is also the author of several books on validation, IT compliance, GMP documentation and processes.\nKey Takeaways\nBy attending this course, delegates will:\n\nIdentify CSV and DI Requirements\nUnderstand validation projects and goals\nLifecycle data and system lifecycle\nOperational understand what and how to do it – and why\nIntegration use it in your daily business\nBuild a landscape and roadmap to compliance\n\nWho Should Attend\n\nSenior Management / CEO\nQualified Person / Responsible Person\nHead of QA, Production and QC\nValidation and Qualification Teams\nInspectors and Investigators\nValidation Experts\nPeople willing to be a game changer in the company\n\n\nFor participation details contact\nMithun Siddartha\nmithun.siddartha@biiworld.com ( mailto:mithun.siddartha@biiworld.com )\n+1 780 851 7197 (Canada)\nFill the details below to request your Brochure\n\nvar gform;gform||(document.addEventListener("gform_main_scripts_loaded",function(){gform.scriptsLoaded=!0}),document.addEventListener("gform/theme/scripts_loaded",function(){gform.themeScriptsLoaded=!0}),window.addEventListener("DOMContentLoaded",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>"function"==typeof InitializeEditor,callIfLoaded:function(o){return!(!gform.domLoaded||!gform.scriptsLoaded||!gform.themeScriptsLoaded&&!gform.isFormEditor()||(gform.isFormEditor()&&console.warn("The use of gform.initializeOnLoaded() is deprecated in the form editor context and will be removed in Gravity Forms 3.1."),o(),0))},initializeOnLoaded:function(o){gform.callIfLoaded(o)||(document.addEventListener("gform_main_scripts_loaded",()=>{gform.scriptsLoaded=!0,gform.callIfLoaded(o)}),document.addEventListener("gform/theme/scripts_loaded",()=>{gform.themeScriptsLoaded=!0,gform.callIfLoaded(o)}),window.addEventListener("DOMContentLoaded",()=>{gform.domLoaded=!0,gform.callIfLoaded(o)}))},hooks:{action:{},filter:{}},addAction:function(o,r,e,t){gform.addHook("action",o,r,e,t)},addFilter:function(o,r,e,t){gform.addHook("filter",o,r,e,t)},doAction:function(o){gform.doHook("action",o,arguments)},applyFilters:function(o){return gform.doHook("filter",o,arguments)},removeAction:function(o,r){gform.removeHook("action",o,r)},removeFilter:function(o,r,e){gform.removeHook("filter",o,r,e)},addHook:function(o,r,e,t,n){null==gform.hooks[o][r]&&(gform.hooks[o][r]=[]);var d=gform.hooks[o][r];null==n&&(n=r+"_"+d.length),gform.hooks[o][r].push({tag:n,callable:e,priority:t=null==t?10:t})},doHook:function(r,o,e){var t;if(e=Array.prototype.slice.call(e,1),null!=gform.hooks[r][o]&&((o=gform.hooks[r][o]).sort(function(o,r){return o.priority-r.priority}),o.forEach(function(o){"function"!=typeof(t=o.callable)&&(t=window[t]),"action"==r?t.apply(null,e):e[0]=t.apply(null,e)})),"filter"==r)return e[0]},removeHook:function(o,r,t,n){var e;null!=gform.hooks[o][r]&&(e=(e=gform.hooks[o][r]).filter(function(o,r,e){return!!(null!=n&&n!=o.tag||null!=t&&t!=o.priority)}),gform.hooks[o][r]=e)}});\n\n\n                \n                        \n                            Individual Training Contact form\n                            \n                        \n                        Full Name(Required)\n                            \n                            \n                                                    \n                                                    First\n                                                \n                            \n                            \n                                                    \n                                                    Last\n                                                \n                            \n                        Job Title(Required)Company Name(Required)Email(Required)\n                            \n                        Contact Number(Required)\n          \n            \n            \n            \n            \n            \n            \n            \n            \n            \n            \n            \n            \n        \n                        \n                        \ngform.initializeOnLoaded( function() {gformInitSpinner( 1, 'https://biiworld.com/wp-content/plugins/gravityforms/images/spinner.svg', true );jQuery('#gform_ajax_frame_1').on('load',function(){var contents = jQuery(this).contents().find('*').html();var is_postback = contents.indexOf('GF_AJAX_POSTBACK') >= 0;if(!is_postback){return;}var form_content = jQuery(this).contents().find('#gform_wrapper_1');var is_confirmation = jQuery(this).contents().find('#gform_confirmation_wrapper_1').length > 0;var is_redirect = contents.indexOf('gformRedirect(){') >= 0;var is_form = form_content.length > 0 && ! 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URL:https://biiworld.com/trainings/gxp-good-practices-10-12-march-2025/
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