{"id":1184,"date":"2019-02-05T09:00:18","date_gmt":"2019-02-05T08:00:18","guid":{"rendered":"https:\/\/swissbiotechcenter.com\/2019\/02\/05\/new-open-training-gmp-mid-level-april-30th-may-1st-2019\/"},"modified":"2019-04-10T11:26:50","modified_gmt":"2019-04-10T09:26:50","slug":"new-open-training-gmp-mid-level-april-30th-may-1st-2019","status":"publish","type":"post","link":"https:\/\/swissbiotechcenter.com\/en\/2019\/02\/05\/new-open-training-gmp-mid-level-april-30th-may-1st-2019\/","title":{"rendered":"NEW OPEN Training: GMP mid-level, April 30th &#038; May 1st 2019"},"content":{"rendered":"<p><strong>Swiss Biotech Center is pleased to organize this year a series of training sessions for professionals in collaboration with Biotech Training Facility, a well-known training organization in the Netherlands. These sessions will take place at the BioArk technology site in Monthey (Switzerland). Discover the program of <\/strong><strong>our upcoming <\/strong><strong>GMP mid-level session and register now!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>The kickoff for this series of training sessions is a 2-day GMP mid-level training course, from April 30<sup>th<\/sup> to May 1<sup>st<\/sup>\u00a0 2019. The training\u2019s program has been optimized for small-sized group and contains <strong>theory as well as practice<\/strong>, plus an <strong>exclusive visit <\/strong>of the Swiss Biotech Center facility! It\u2019s ideal for professionals who want or need to know more about GMP (such as QA\/QC) and operations staff performing GMP activities and looking for continuing training.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Short description of the training<\/strong><\/p>\n<p>A solid GMP training is a basic requirement for working in the pharmaceutical industry. With a very efficient and practical method given by Biotech Training Facility, you will learn the basics of GMP.<\/p>\n<p>Theory and practice go hand in hand during this course, which enables the participants to put all acquired knowledge and skills immediately into practice.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Objectives<\/strong><\/p>\n<p>Increased awareness and knowledge of the following topics:<\/p>\n<ul>\n<li>Basic principles of GMP<\/li>\n<li>History of GMP legislation<\/li>\n<li>Basic elements of various quality systems in pharmaceutical companies, including Out of Specification (OOS), deviations, change control, GMP documentation, outsourcing of work and process validation<\/li>\n<li>GMP requirements for equipment and facilities<\/li>\n<li>Basic principles of risk analysis within the pharmaceutical industry<\/li>\n<li>Data integrity rules<\/li>\n<li>Basics of microbiology and contamination control<\/li>\n<li>Performing environmental monitoring<\/li>\n<li>Basic principles of GMP within a QC laboratory<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Target group<\/strong><\/p>\n<p>Anyone who wants or needs to know more about GMP, such as QA, QC, and operations staff who perform GMP activities. The training is limited to 12 participants (2 trainers)<\/p>\n<p>&nbsp;<\/p>\n<p><strong>PROGRAMME<\/strong><\/p>\n<table style=\"height: 108px; width: 743px;\">\n<tbody>\n<tr>\n<td style=\"width: 199px;\">Day 1 | April 30<\/td>\n<td style=\"width: 558px;\">Start time : 8:30 | End time : 17:00<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 757px;\" colspan=\"2\"><strong>Theory<\/strong><\/p>\n<ul>\n<li>Introduction to GMP history, legislation and basic principles<\/li>\n<li>Quality systems within the pharmaceutical industry, including<br \/>\n&#8211; Deviations<br \/>\n&#8211; Change control<br \/>\n&#8211; Training<\/li>\n<li>Deviations and Out of Specifications<\/li>\n<li>GMP documentation<br \/>\n&#8211; Basic principles<br \/>\n&#8211; Importance of GMP documentation<\/li>\n<li>GMP facility and equipment<br \/>\n&#8211; Qualification of facilities and equipment<br \/>\n&#8211; Calibrations<br \/>\n&#8211; Labelling of equipment<br \/>\n&#8211; Preventing (cross) contamination<\/li>\n<li>Data integrity, including:<br \/>\n&#8211; Importance of data integrity<br \/>\n&#8211; ALCOA principles (Attributable, Legible, Contemporaneous, Original and Accurate)<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 757px;\" colspan=\"2\"><strong>Pratice<\/strong><\/p>\n<ul>\n<li>Tour of Swiss Biotech Center GMP cleanrooms<\/li>\n<li>Making a buffer while GMP activities are being simulated, including:<br \/>\n&#8211; Following a batch production record<br \/>\n&#8211; Filling in a batch production record<br \/>\n&#8211; Use of raw materials<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table style=\"height: 108px; width: 745px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 195px; height: 24px;\">Day 2 | May 1st<\/td>\n<td style=\"width: 562px; height: 24px;\">Start time : 8:30 | End time : 17:00<\/td>\n<\/tr>\n<tr style=\"height: 408px;\">\n<td style=\"width: 757px; height: 408px;\" colspan=\"2\"><strong>Theory<\/strong><\/p>\n<ul>\n<li>QC activities<br \/>\n&#8211; Role of QC<br \/>\n&#8211; Documentation related to QC labs, such as specifications<br \/>\n&#8211; Reagents<br \/>\n&#8211; Reference standards<\/li>\n<li>Outsourcing of pharmaceutical activities<\/li>\n<li>Change control<\/li>\n<li>Risk assessment within the pharmaceutical industry<br \/>\n&#8211; Basic principles of ICH Q9<br \/>\n&#8211; FMEA technique (Failure Mode Effect Analysis)<br \/>\n&#8211; Risk ranking<\/li>\n<li>Contamination control, including:<br \/>\n&#8211;\u00a0 Basic principles of microbiology<br \/>\n&#8211;\u00a0 How to avoid microbial contamination of the product ?<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr style=\"height: 144px;\">\n<td style=\"width: 757px; height: 144px;\" colspan=\"2\"><strong>Pratice<\/strong><\/p>\n<ul>\n<li>Workshop: a risk assessment is performed in order to determine the risks in case of a production\/material change<\/li>\n<li>Perform environmental monitoring tests<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<table style=\"width: 230px;\">\n<tbody>\n<tr>\n<td style=\"width: 232px;\">SESSION OVERVIEW<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table style=\"width: 744px;\">\n<tbody>\n<tr style=\"height: 192px;\">\n<td style=\"width: 750px; height: 192px; background-color: #bb4732; color: #ffffff;\">Start time : 30.04.2019<br \/>\nEnd time : 01.05.2019<br \/>\nLanguage : English<br \/>\nCours fee : 2,500 CHF<br \/>\nPlaces available : max. 12<br \/>\nLocation : BioArk Monthey (CH)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><strong>INSCRIPTION\u00a0 &amp; INFORMATION<\/strong><\/p>\n<table style=\"width: 746px;\">\n<tbody>\n<tr style=\"height: 12px;\">\n<td style=\"width: 756px; height: 12px;\">CONTACT FORM<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>[wpforms id=&#8221;1351&#8243; title=&#8221;false&#8221; description=&#8221;false&#8221;]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Swiss Biotech Center is pleased to organize this year a series of training sessions for professionals in collaboration with Biotech Training Facility, &hellip; <\/p>\n<p><a href=\"https:\/\/swissbiotechcenter.com\/en\/2019\/02\/05\/new-open-training-gmp-mid-level-april-30th-may-1st-2019\/\" class=\"read-more-btn btn btn-small\">Read More<span class=\"screen-reader-text\">NEW OPEN Training: GMP mid-level, April 30th &#038; May 1st 2019<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":1316,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44],"tags":[],"class_list":["post-1184","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>NEW OPEN Training: GMP mid-level, April 30th &amp; May 1st 2019 - Swiss Biotech Center<\/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:\/\/swissbiotechcenter.com\/en\/2019\/02\/05\/new-open-training-gmp-mid-level-april-30th-may-1st-2019\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NEW OPEN Training: GMP mid-level, April 30th &amp; 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