{"id":44702,"date":"2022-11-25T17:02:02","date_gmt":"2022-11-25T10:02:02","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=44702"},"modified":"2022-11-26T09:00:43","modified_gmt":"2022-11-26T02:00:43","slug":"contamination-control-strategy-ccs-for-annex-1-viable-monitoring","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/contamination-control-strategy-ccs-for-annex-1-viable-monitoring\/","title":{"rendered":"Contamination Control Strategy (CCS) for ANNEX 1 Viable Monitoring"},"content":{"rendered":"\n\t<section class=\"section\" id=\"section_1979759152\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1388864371\">\n\n\n\t<div id=\"col-1858648328\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div id=\"text-2359283284\" class=\"text\">\n\t\t\n\n<h2 class=\"banner-title\" style=\"text-align: left;\"><span style=\"font-size: 110%;\">On Demand Webinar<\/span><\/h2>\n\t\t\n<style>\n#text-2359283284 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-2359283284 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1858648328 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: -12px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1979759152 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1979759152 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/banner-webinars.png);\n}\n#section_1979759152 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1979759152 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\t<section class=\"section\" id=\"section_333572778\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-136969928\">\n\n\n\t<div id=\"col-703354540\" class=\"col medium-9 small-12 large-9\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2><span data-text-color=\"alert\">Microbial Monitoring Solutions<\/span><\/h2>\n<h3><span data-text-color=\"alert\">Prepare Your Contamination Control Strategy (CCS) for EU GMP ANNEX 1<\/span><\/h3>\n<p>While the new Annex 1 is still in draft stage, the drafts tell us clearly where the committee is heading as far as priorities and gives us guidelines that we can apply now to your Contamination Control Strategy (CCS) (including a cleanroom monitoring plan) to be ready for the final Annex 1 update release. The\u00a0<span data-text-color=\"alert\"><strong>New Annex 1<\/strong><\/span>\u00a0has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by\u00a0<span data-text-color=\"alert\">Particle Measuring Systems (PMS)<\/span>\u00a0experts focuses on the\u00a0<strong><span data-text-color=\"alert\">Viable\/Microbial Air Monitoring<\/span>\u00a0<\/strong>aspects including:<\/p>\n<ul>\n<li>Designing an effective\u00a0<strong><span data-text-color=\"alert\">Contamination Control Strategy<\/span>\u00a0(CCS)<\/strong>\u00a0based on a scientific assessment to understand the process and to apply risk management principles.<\/li>\n<li>Newest Annex 1\u00a0<span data-text-color=\"alert\"><strong>Single Use Requirements<\/strong><\/span>\u00a0relevant solutions<\/li>\n<li><span data-text-color=\"alert\"><strong>Microbial Plate Incubation<\/strong><\/span>\u00a0and\u00a0<strong>Pharmaceutical Risk Assessments<\/strong><\/li>\n<li>Importance of\u00a0<span data-text-color=\"alert\"><strong>Continuous Viable Air Monitoring<\/strong><\/span><\/li>\n<li>How the underlying need of a\u00a0<strong><span data-text-color=\"alert\">Quality Risk Management (QRM)<\/span>\u00a0<\/strong>approach, along with\u00a0<span data-text-color=\"alert\">Risk Assessments<\/span>\u00a0based on science are to be the fundamental principles driving decisions to protect product quality<\/li>\n<li>When, Where, and How to do\u00a0<span data-text-color=\"alert\"><strong>Environmental Monitoring<\/strong><\/span>\u00a0and a cleanroom monitoring plan.<\/li>\n<li>Changes in\u00a0<span data-text-color=\"alert\"><strong>Viable Monitoring Requirements<\/strong><\/span><\/li>\n<li>Solutions to meet these cleanroom monitoring requirements<\/li>\n<li>Concepts regarding the requirements for a\u00a0<span data-text-color=\"alert\"><strong>Pharmaceutical Risk Assessment<\/strong><\/span>\u00a0to set appropriate\u00a0<strong>Microbial Plate Conditions<\/strong>\u00a0<\/li>\n<li>Much more!<\/li>\n<\/ul>\n<p>During the live webinar we had several questions submitted and made these into an<strong>\u00a0<span data-text-color=\"alert\">Annex 1 Microbial FAQ paper<\/span>\u00a0<\/strong>that you can access at any time.<\/p>\n<h3 style=\"text-align: center;\"><span data-text-color=\"alert\">Complete the form to access the on-demand webinar.<\/span><\/h3>\n<p>Ready to get started with a\u00a0<em><strong>cleanroom monitoring plan<\/strong><\/em>\u00a0and\u00a0<strong><em>Contamination Control Strategy<\/em><\/strong>? Learn about Particle Measuring Systems PMS\u00a0<em><strong><span data-text-color=\"alert\">complete environmental monitoring solutions<\/span>\u00a0<\/strong><\/em>for\u00a0<span data-text-color=\"alert\">Pharmaceutical Manufacturers<\/span>.<\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-75992152\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_836935848\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"275\" height=\"424\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/bacteria.png\" class=\"attachment-large size-large\" alt=\"bacteria\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_836935848 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1818281580\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1156502154\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_2076101011\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"206\" height=\"55\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/email-buttons-learn-more.png\" class=\"attachment-large size-large\" alt=\"email buttons learn more\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_2076101011 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1156502154 > .col-inner {\n  margin: 0px 0px 0px 25px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1531594384\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p>Get started with your cleanroom microbial data collection and management. Particle Measuring Systems has a full suite of options for you:<\/p>\n<ul>\n<li><span data-text-color=\"alert\">Cleanroom Contamination Control Advisory services<\/span><\/li>\n<li><span data-text-color=\"alert\">Microbial impactors<\/span>, including single-use for\u00a0<span data-text-color=\"alert\">continuous sampling<\/span><\/li>\n<li><span data-text-color=\"alert\">Active Air samplers<\/span><\/li>\n<li><span data-text-color=\"alert\">Data management\u00a0<\/span><\/li>\n<\/ul>\n<p>Particle Measuring Systems has\u00a0<strong><span data-text-color=\"alert\">complete cleanroom contamination control solutions<\/span>\u00a0<\/strong>to help you meet EU GMP including:<\/p>\n<ul>\n<li>Our\u00a0<span data-text-color=\"alert\">Contamination Control Advisory Services<\/span>\u00a0can conduct an expert Risk Assessment for your pharmaceutical processes<\/li>\n<li><span data-text-color=\"alert\">PMS cleanroom particle counters<\/span>\u00a0including\u00a0<span data-text-color=\"alert\">portable\/mobile<\/span>\u00a0and\u00a0<span data-text-color=\"alert\">fixed\/remote<\/span><\/li>\n<li><span data-text-color=\"alert\">Microbial monitors<\/span>\u00a0including\u00a0<span data-text-color=\"alert\">portable\/mobile<\/span>,\u00a0<span data-text-color=\"alert\">fixed\/remote<\/span>, and\u00a0<span data-text-color=\"alert\">single-use<\/span>.<\/li>\n<li><span data-text-color=\"alert\">Data management software<\/span>\u00a0from Particle Measuring Systems<\/li>\n<li>Customizable, turnkey\u00a0<span data-text-color=\"alert\">Facility Monitoring Systems (FMS)<\/span><\/li>\n<\/ul>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-2070256472\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-812354175\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1096880654\">\n\t\t<a class=\"\" href=\"https:\/\/techmaster.com.vn\/en\/contact\/#request\"  >\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"200\" height=\"40\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/email-buttons-GET-A-QUOTE-small-1.png\" class=\"attachment-large size-large\" alt=\"email buttons GET A QUOTE small\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/a>\t\t\n<style>\n#image_1096880654 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-812354175 > .col-inner {\n  margin: 0px 0px 0px 25px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2003614321\" class=\"col medium-5 small-12 large-5\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-417502816\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1001758823\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"181\" height=\"191\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/speaker1.jpeg\" class=\"attachment-large size-large\" alt=\"\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1001758823 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1781010458\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<div class=\"presenter-role\"><span style=\"color: #0d6d72;\">PRESENTER<\/span><\/div>\n<h4 class=\"presenter-name\"><span data-text-color=\"alert\">Dr. Frank Panofen<\/span><\/h4>\n<div class=\"presenter-position\">PhD, Life Science Division, Product Line Manager Microbials, Particle Measuring Systems<\/div>\n<div class=\"presenter-bio\">\n<p>Dr. Panofen has a Diploma in Chemistry from the University of Bielefeld and a PhD in molecular and cell biology from the University of Osnabr\u00fcck. He has expansive experience in the field of applied pharmaceutical microbiology and serves as the Sterility Assurance\/Microbiology Product Line Manager at Particle Measuring Systems. Frank has been an invited speaker at international conferences including ECA and PDA, with a strong regulatory background in pharmaceuticals. He is a certified Microbiological Laboratory Manager from ECA.<\/p>\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1781010458 > .col-inner {\n  margin: 0px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-974344350\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_515052717\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"152\" height=\"181\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/Artalli-Guillia-web-152x181-1.jpeg\" class=\"attachment-large size-large\" alt=\"\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_515052717 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-188129648\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<div class=\"presenter-role\"><span style=\"color: #0d6d72;\">PRESENTER<\/span><\/div>\n<h4 class=\"presenter-name\"><span data-text-color=\"alert\">Giulia Artalli<\/span><\/h4>\n<div class=\"presenter-position\">Global Product Line Manager, Particle Measuring Systems<\/div>\n<div class=\"presenter-bio\">\n<p>Dr. Artalli has a degree in biology from the University of Milan with over 20 years\u2019 experience in Microbiology, specifically for pharmaceutical applications.<br \/>Dr. Artalli has covered different roles acquiring knowledge on different topics useful for supporting customers in their needs; she is a Global Product Line Manager at Particle Measuring Systems for the Microbiology product line.<\/p>\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-188129648 > .col-inner {\n  margin: 0px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1681031344\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1327949721\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"152\" height=\"181\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/Paola-Headshot-IMG-1-1.jpeg\" class=\"attachment-large size-large\" alt=\"\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1327949721 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-458166472\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<div class=\"presenter-role\"><span style=\"color: #0d6d72;\">PRESENTER<\/span><\/div>\n<h4 class=\"presenter-name\"><span data-text-color=\"alert\">Paola Lazzeri<\/span><\/h4>\n<div class=\"presenter-position\">EMEA Field Application Specialist Sterility Assurance\/Microbiology, Particle Measuring Systems<\/div>\n<div class=\"presenter-bio\">\n<p>Paola has extensive professional experience over 14+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. She maintains this expertise through constant dialogue with Quality Officers, Production and Financial teams in the various industries she works with. She actively collaborates with the PMS Advisory Team on decontamination strategy using a Quality Risk Management approach and assists Pharma companies with the validation of sanitizing and decontaminating agents. Paola also regularly writes technical articles and participates as a speaker at national and international Pharma conferences.<\/p>\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-458166472 > .col-inner {\n  margin: 0px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_333572778 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_333572778 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_333572778 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":44708,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-44702","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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