{"id":34790,"date":"2020-11-09T14:44:16","date_gmt":"2020-11-09T14:44:16","guid":{"rendered":"https:\/\/www.biotechpharmasummit.com\/?page_id=34790"},"modified":"2021-03-18T10:04:47","modified_gmt":"2021-03-18T10:04:47","slug":"susan-cleary","status":"publish","type":"page","link":"https:\/\/www.biotechpharmasummit.com\/index.php\/aseptic-processing-technology-2021-speakers\/susan-cleary\/","title":{"rendered":"Susan Cleary"},"content":{"rendered":"<div class=\"vgblk-rw-wrapper limit-wrapper\">\n<h2>Susan Cleary<\/h2>\n<h4>Director of Product Development at Novatek International<\/h4>\n\t<p>Susan B. Cleary, B.Cs, M.B.A., is the Director of Product Development at Novatek International. Previously holding the positions of Program Manager, Product Manager, and Lead Engineer for Environmental Monitoring systems. Susan has 20 years of experience in designing, developing, implementing, and managing large scale Quality Management, Environmental Monitoring and Cleaning Validation Management implementations.<\/p>\n<p>Susan works with pharmaceutical, biotech, and medical device companies and specializes in Data Integrity, she works with clients to streamline their procedures and manage their GMP compliantly and effectively. -Co-Author: PDA Book, Environmental Monitoring Volume 2, Chapter 25 -Trainer: Validation Mentor for Institute of Validation Technologies -Co-Author: PDA Book, Environmental Monitoring, Volume 6, Chapter 16 -Trainer: PDA Training Institute, Case Study on Root Cause Analysis for Aseptic Processing -Co-Author: PDA Book, Contamination Control, Volume 4 Chapter 12 -Co-Author: Springer Book for Stability Methods., Risk Based Stability Management -Over 20 Published Articles and Presentations at PDA, Interphex, IVT, KENX, and others<\/p>\n\t\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1.jpg\" alt=\"Payam Montazami Fine Arts\" itemprop=\"image\" height=\"1224\" width=\"820\" title=\"Payam Montazami Fine Arts\" onerror=\"this.style.display='none'\" sizes=\"(max-width: 768px) 100vw, 100vw\" srcset=\"data:image\/svg+xml;utf8,<svg%20xmlns=&quot;http:\/\/www.w3.org\/2000\/svg&quot;%20viewBox=&quot;0%200%20820%201224&quot;%20height=&quot;1224px&quot;%20width=&quot;820px&quot;\/>&#8221; data-srcset=&#8221;https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1.jpg 820w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-201&#215;300.jpg 201w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-686&#215;1024.jpg 686w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-768&#215;1146.jpg 768w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-630&#215;940.jpg 630w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-420&#215;627.jpg 420w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/11\/Novatek_Susan_Cleary_BioTech_Pharma_Summit_2021_Profile_1-315&#215;470.jpg 315w&#8221;>\t\t\t\t\t\t\t\n<h3>\n\tTitle: Learn How to Trend &amp; Analyze Environmental Monitoring Data \n\t<\/h3>\n<div class=\"su-expand su-expand-collapsed su-expand-link-style-default\" data-height=\"200\"><div class=\"su-expand-content su-u-trim\" style=\"color:#333333;max-height:200px;overflow:hidden\">\n<p>This presentation will cover two areas critical to the Aseptic Processing space.<\/p>\n<p><strong>Part 1: EM Trending Requirements <\/strong><\/p>\n<ul>\n<li>Overview on requirements and guidelines on EM data analysis<\/li>\n<li>Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data<\/li>\n<li>Routine Environmental Monitoring Reporting for State of Control including Recovery Rate Reports, Control Charts, Continuous Monitoring Trends, Microorganism Trends and Linear Regression by sampling sites o Review of method for trending o Frequency of trending o Data parameters used o Filtering and grouping data<\/li>\n<li>Understanding the meaning of EM data trends including risk identification, pattern recognition, actions required, and conclusions<\/li>\n<\/ul>\n<p><strong>Part 2: Trending for Root Cause Analysis <\/strong><\/p>\n<ul>\n<li>Non-Routine data analysis for assisting in investigations including o Assessing root cause and assessment of impact to product including comparison of personnel, equipment, product sampling sites, media, microorganisms, occupant count, proximity to process\/product. o Setting appropriate alert measures required for maintaining a state of control based on data including pattern recognition (rolling specifications), adverse trends, and non-conformances.<\/li>\n<li>Using EM data analysis as part of a continuous improvement to EM program improvements<\/li>\n<li>The transition from a paper base system to an automation solution.<\/li>\n<\/ul>\n<\/div><div class=\"su-expand-link su-expand-link-more\" style=\"text-align:left\"><a href=\"javascript:;\" style=\"color:#0088FF;border-color:#0088FF\"><span style=\"border-color:#0088FF\">Show more<\/span><\/a><\/div><div class=\"su-expand-link su-expand-link-less\" style=\"text-align:left\"><a href=\"javascript:;\" style=\"color:#0088FF;border-color:#0088FF\"><span style=\"border-color:#0088FF\">Show less<\/span><\/a><\/div><\/div>\n<h4>\n\t\t\t<a href=\"#\" title=\"On the Web\" target=\"_self\" rel=\"noopener noreferrer\">\n\tOn the Web\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/ntint.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/ntint.com\/<\/a><\/p>\n<h4>\n\t\t\t<a href=\"#\" title=\"On LinkedIn\" target=\"_self\" rel=\"noopener noreferrer\">\n\tOn LinkedIn\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/www.linkedin.com\/in\/susan-cleary-15485b3\/\" target=\"_blank\" rel=\"noopener noreferrer\">Visit Profile<\/a><\/p>\n<\/div><!-- .vgblk-rw-wrapper -->","protected":false},"excerpt":{"rendered":"<p>Susan Cleary Director of Product Development at Novatek International Susan B. Cleary, B.Cs, M.B.A., is the Director of Product Development at Novatek International. Previously holding the positions of Program Manager, Product Manager, and Lead Engineer for Environmental Monitoring systems. Susan has 20 years of experience in designing, developing, implementing, and managing large scale Quality Management,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":34791,"parent":34768,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-34790","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Susan Cleary &#8226; BioTech Pharma Summit<\/title>\n<meta name=\"description\" content=\"Susan B. Cleary, B.Cs, M.B.A., is the Director of Product Development at Novatek International. 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