{"id":2733,"date":"2026-01-05T11:35:47","date_gmt":"2026-01-05T04:35:47","guid":{"rendered":"https:\/\/filterfinevn.com\/?p=2733"},"modified":"2026-01-05T11:43:13","modified_gmt":"2026-01-05T04:43:13","slug":"english-hoi-thao-truc-tuyen-lws-dinh-vi-dau-do-khi-nen-dua-tren-rui-ro-trong-san-xuat-vo-trung","status":"publish","type":"post","link":"https:\/\/filterfinevn.com\/en\/english-hoi-thao-truc-tuyen-lws-dinh-vi-dau-do-khi-nen-dua-tren-rui-ro-trong-san-xuat-vo-trung\/","title":{"rendered":"WEBINAR LWS: Risk-Based Airborne Probe Placement for Sterile Manufacturing"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-2734\" src=\"https:\/\/filterfinevn.com\/wp-content\/uploads\/2026\/01\/risk-based-airborne-probe-webinar-graphic.png\" alt=\"\" width=\"1200\" height=\"627\" srcset=\"https:\/\/filterfinevn.com\/wp-content\/uploads\/2026\/01\/risk-based-airborne-probe-webinar-graphic.png 1200w, https:\/\/filterfinevn.com\/wp-content\/uploads\/2026\/01\/risk-based-airborne-probe-webinar-graphic-1024x535.png 1024w, https:\/\/filterfinevn.com\/wp-content\/uploads\/2026\/01\/risk-based-airborne-probe-webinar-graphic-768x401.png 768w, https:\/\/filterfinevn.com\/wp-content\/uploads\/2026\/01\/risk-based-airborne-probe-webinar-graphic-510x266.png 510w\" sizes=\"auto, (max-width: 706px) 89vw, (max-width: 767px) 82vw, 740px\" \/><\/p>\n<h2 data-start=\"281\" data-end=\"302\">Webinar Overview<\/h2>\n<h3 data-start=\"303\" data-end=\"382\">Building a Science-Based, Risk-Driven Environmental Monitoring (EM) Program<\/h3>\n<p data-start=\"384\" data-end=\"623\">For many years, legacy <strong data-start=\"407\" data-end=\"440\">Environmental Monitoring (EM)<\/strong> programs have placed fixed probes in \u201cconvenient\u201d locations without clear scientific rationale or documented risk assessment. This approach is <strong data-start=\"584\" data-end=\"622\">no longer acceptable to regulators<\/strong>.<\/p>\n<p data-start=\"625\" data-end=\"912\">This webinar introduces a <strong data-start=\"651\" data-end=\"686\">practical, repeatable framework<\/strong> for determining where <strong data-start=\"709\" data-end=\"748\">isokinetic airborne particle probes<\/strong> should be placed so that collected data truly reflect <strong data-start=\"803\" data-end=\"855\">actual contamination risk to the aseptic process<\/strong>, rather than background noise or original design intent.<\/p>\n<p data-start=\"914\" data-end=\"1039\">Participants will learn a <strong data-start=\"940\" data-end=\"962\">nine-step workflow<\/strong> aligned with <strong data-start=\"976\" data-end=\"999\">EU GMP Annex 1:2022<\/strong> and <strong data-start=\"1004\" data-end=\"1024\">ISO 14644-1:2015<\/strong>, supported by:<\/p>\n<ul>\n<li data-start=\"1042\" data-end=\"1063\">Real-world examples<\/li>\n<li data-start=\"1066\" data-end=\"1092\">A ready-to-use checklist<\/li>\n<li data-start=\"1095\" data-end=\"1201\">Practical probe placement principles combining <strong data-start=\"1142\" data-end=\"1201\">process knowledge, airflow science, and risk assessment<\/strong><\/li>\n<\/ul>\n<h2 data-start=\"1208\" data-end=\"1228\">Who Should Attend<\/h2>\n<ul>\n<li data-start=\"1232\" data-end=\"1275\">QA \/ QC managers in sterile manufacturing<\/li>\n<li data-start=\"1278\" data-end=\"1337\">Environmental Monitoring (EM) specialists and technicians<\/li>\n<li data-start=\"1340\" data-end=\"1407\">HVAC and Facility Engineering teams supporting aseptic operations<\/li>\n<li data-start=\"1410\" data-end=\"1455\">Production managers and batch record owners<\/li>\n<li data-start=\"1458\" data-end=\"1507\">Regulatory Affairs and Compliance professionals<\/li>\n<li data-start=\"1510\" data-end=\"1572\">GMP consultants supporting audits and FDA Form 483 responses<\/li>\n<li data-start=\"1575\" data-end=\"1640\">Sterile manufacturing facility directors and operations leaders<\/li>\n<\/ul>\n<h2 data-start=\"1647\" data-end=\"1671\">Why You Should Attend<\/h2>\n<h3 data-start=\"1673\" data-end=\"1713\">1. Regulatory Pressure Is Increasing<\/h3>\n<p data-start=\"1715\" data-end=\"1887\">Recent <strong data-start=\"1722\" data-end=\"1751\">FDA Form 483 observations<\/strong>, internal audits, and EU GMP inspections increasingly challenge EM programs that lack <strong data-start=\"1838\" data-end=\"1886\">documented justification for probe placement<\/strong>.<\/p>\n<p data-start=\"1889\" data-end=\"1933\"><strong data-start=\"1889\" data-end=\"1905\">Annex 1:2022<\/strong> explicitly requires that:<\/p>\n<blockquote data-start=\"1934\" data-end=\"2027\">\n<p data-start=\"1936\" data-end=\"2027\"><em data-start=\"1936\" data-end=\"2027\">\u201cMonitoring locations should be appropriate to obtain reliable data from critical zones.\u201d<\/em><\/p>\n<\/blockquote>\n<p data-start=\"2029\" data-end=\"2087\">Placing probes simply \u201cto comply\u201d is no longer sufficient.<\/p>\n<h3 data-start=\"2094\" data-end=\"2125\">2. Data Quality Is Critical<\/h3>\n<p data-start=\"2127\" data-end=\"2173\">Incorrectly positioned probes often result in:<\/p>\n<ul>\n<li data-start=\"2176\" data-end=\"2200\">Sudden particle spikes<\/li>\n<li data-start=\"2203\" data-end=\"2217\">False alarms<\/li>\n<li data-start=\"2220\" data-end=\"2253\">Unreliable or misleading trends<\/li>\n<\/ul>\n<p data-start=\"2255\" data-end=\"2343\">\u27a1 These issues drive unnecessary investigations and consume significant QA\/QC resources.<\/p>\n<h3 data-start=\"2350\" data-end=\"2391\">3. A Science- and Risk-Based Approach<\/h3>\n<p data-start=\"2393\" data-end=\"2419\">This framework integrates:<\/p>\n<ul>\n<li data-start=\"2422\" data-end=\"2442\"><strong data-start=\"2422\" data-end=\"2440\">EU GMP Annex 1<\/strong><\/li>\n<li data-start=\"2445\" data-end=\"2462\"><strong data-start=\"2445\" data-end=\"2460\">ISO 14644-1<\/strong><\/li>\n<li data-start=\"2465\" data-end=\"2503\"><strong data-start=\"2465\" data-end=\"2501\">ICH Q9 \u2013 Quality Risk Management<\/strong><\/li>\n<li data-start=\"2506\" data-end=\"2549\"><strong data-start=\"2506\" data-end=\"2547\">Smoke studies (airflow visualization)<\/strong><\/li>\n<\/ul>\n<p data-start=\"2551\" data-end=\"2640\">\u27a1 Proven to work across <strong data-start=\"2575\" data-end=\"2639\">filling lines, compounding areas, RABS, and isolator systems<\/strong>.<\/p>\n<h2 data-start=\"2647\" data-end=\"2688\">Core Methodology \u2013 The 9-Step Workflow<\/h2>\n<h3 data-start=\"2690\" data-end=\"2745\">Step 1: Define Scope and Critical Operating Areas<\/h3>\n<p data-start=\"2746\" data-end=\"2888\">Clarify the process, identify product exposure points, and recognize high-risk influences such as doors, airlocks, and operator interventions.<\/p>\n<h3 data-start=\"2895\" data-end=\"2946\">Step 2: Collect Design and Historical EM Data<\/h3>\n<p data-start=\"2947\" data-end=\"2954\">Review:<\/p>\n<ul>\n<li data-start=\"2957\" data-end=\"2988\">HVAC and HEPA layout drawings<\/li>\n<li data-start=\"2991\" data-end=\"3025\">Cleanroom classification results<\/li>\n<li data-start=\"3028\" data-end=\"3064\">Deviations, OOS events, and alarms<\/li>\n<li data-start=\"3067\" data-end=\"3099\">Existing probe and sensor maps<\/li>\n<\/ul>\n<p data-start=\"3101\" data-end=\"3180\">\u27a1 Understand how the cleanroom actually performs, not just how it was designed.<\/p>\n<h3 data-start=\"3187\" data-end=\"3239\">Step 3: Conduct a Cross-Functional Walkthrough<\/h3>\n<p data-start=\"3240\" data-end=\"3325\">Perform an on-site walkthrough with <strong data-start=\"3276\" data-end=\"3315\">Production, QA, Engineering, and EM<\/strong>, mapping:<\/p>\n<ul>\n<li data-start=\"3328\" data-end=\"3344\">Personnel flow<\/li>\n<li data-start=\"3347\" data-end=\"3361\">Product flow<\/li>\n<li data-start=\"3364\" data-end=\"3393\">Material and waste movement<\/li>\n<\/ul>\n<p data-start=\"3395\" data-end=\"3441\">\u27a1 Identify real behaviors versus written SOPs.<\/p>\n<h3 data-start=\"3448\" data-end=\"3508\">Step 4: Perform Smoke Studies Under Dynamic Conditions<\/h3>\n<p data-start=\"3509\" data-end=\"3539\">Visualize airflow to identify:<\/p>\n<ul>\n<li data-start=\"3542\" data-end=\"3559\">First-air paths<\/li>\n<li data-start=\"3562\" data-end=\"3599\">Bounce-back and recirculation zones<\/li>\n<li data-start=\"3602\" data-end=\"3619\">Operator impact<\/li>\n<li data-start=\"3622\" data-end=\"3647\">Door-driven air ingress<\/li>\n<\/ul>\n<h3 data-start=\"3654\" data-end=\"3700\">Step 5: Apply Probe Placement Principles<\/h3>\n<ul>\n<li data-start=\"3703\" data-end=\"3753\">Within approximately <strong data-start=\"3724\" data-end=\"3751\">30 cm of critical zones<\/strong><\/li>\n<li data-start=\"3756\" data-end=\"3794\">Aligned with local airflow direction<\/li>\n<li data-start=\"3797\" data-end=\"3816\">At working height<\/li>\n<li data-start=\"3819\" data-end=\"3860\">Away from short-circuits and dead zones<\/li>\n<\/ul>\n<h3 data-start=\"3867\" data-end=\"3919\">Step 6: Perform Risk Scoring for Each Location<\/h3>\n<p data-start=\"3920\" data-end=\"3929\">Evaluate:<\/p>\n<ul>\n<li data-start=\"3932\" data-end=\"3944\">Likelihood<\/li>\n<li data-start=\"3947\" data-end=\"3955\">Impact<\/li>\n<li data-start=\"3958\" data-end=\"3980\">Detection capability<\/li>\n<\/ul>\n<p data-start=\"3982\" data-end=\"4082\">\u27a1 Determine where <strong data-start=\"4000\" data-end=\"4030\">fixed probes are mandatory<\/strong> versus where <strong data-start=\"4044\" data-end=\"4081\">portable monitoring is sufficient<\/strong>.<\/p>\n<h3 data-start=\"4089\" data-end=\"4140\">Step 7: Standardize Practical Placement Rules<\/h3>\n<p data-start=\"4141\" data-end=\"4178\">Define clear tactics for probes near:<\/p>\n<ul>\n<li data-start=\"4181\" data-end=\"4192\">Operators<\/li>\n<li data-start=\"4195\" data-end=\"4215\">Doors and airlocks<\/li>\n<li data-start=\"4218\" data-end=\"4232\">HEPA returns<\/li>\n<li data-start=\"4235\" data-end=\"4272\">Product and material transfer paths<\/li>\n<\/ul>\n<h3 data-start=\"4279\" data-end=\"4322\">Step 8: Create Maps and Documentation<\/h3>\n<p data-start=\"4323\" data-end=\"4359\">Develop facility drawings including:<\/p>\n<ul>\n<li data-start=\"4362\" data-end=\"4380\">Unique probe IDs<\/li>\n<li data-start=\"4383\" data-end=\"4408\">Placement justification<\/li>\n<li data-start=\"4411\" data-end=\"4438\">Linkage to critical zones<\/li>\n<li data-start=\"4441\" data-end=\"4475\">References to Annex 1 and ICH Q9<\/li>\n<\/ul>\n<hr data-start=\"4477\" data-end=\"4480\" \/>\n<h3 data-start=\"4482\" data-end=\"4526\">Step 9: Verify and Periodically Review<\/h3>\n<ul>\n<li data-start=\"4529\" data-end=\"4607\">Confirm fixed probe data aligns with smoke studies and portable measurements<\/li>\n<li data-start=\"4610\" data-end=\"4687\">Integrate probe locations into the <strong data-start=\"4645\" data-end=\"4685\">Contamination Control Strategy (CCS)<\/strong><\/li>\n<li data-start=\"4690\" data-end=\"4737\">Trigger reviews after process or HVAC changes<\/li>\n<\/ul>\n<h2 data-start=\"4744\" data-end=\"4784\">Value You Will Gain from This Webinar<\/h2>\n<p data-start=\"4786\" data-end=\"4812\">Participants will receive:<\/p>\n<ul>\n<li data-start=\"4815\" data-end=\"4846\">\u2705 A ready-to-use EM checklist<\/li>\n<li data-start=\"4849\" data-end=\"4881\">\u2705 Example probe placement maps<\/li>\n<li data-start=\"4884\" data-end=\"4911\">\u2705 A risk scoring template<\/li>\n<li data-start=\"4914\" data-end=\"4949\">\u2705 Practical decision-making rules.<\/li>\n<\/ul>\n<h3 data-start=\"5266\" data-end=\"5311\">\ud83d\udc49 Register Now with Filterfine Vietnam<\/h3>\n<p data-start=\"5312\" data-end=\"5479\">Join the webinar here:<br data-start=\"5334\" data-end=\"5337\" \/><a class=\"decorated-link\" href=\"https:\/\/www.golighthouse.com\/en\/webinars\/risk-based-airborne-probe-placement-for-sterile-manufacturing-january-16-1am-pacific\/?wspage=register\" target=\"_new\" rel=\"noopener\" data-start=\"5337\" data-end=\"5479\">https:\/\/www.golighthouse.com\/en\/webinars\/risk-based-airborne-probe-placement-for-sterile-manufacturing-january-16-1am-pacific\/?wspage=register<\/a><\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Webinar h\u01b0\u1edbng d\u1eabn \u0111\u1eb7t \u0111\u1ea7u d\u00f2 Environmental Monitoring d\u1ef1a tr\u00ean Annex 1:2022, ISO 14644-1 v\u00e0 \u0111\u00e1nh gi\u00e1 r\u1ee7i ro cho ph\u00f2ng s\u1ea1ch v\u00f4 tr\u00f9ng.<\/p>\n","protected":false},"author":1,"featured_media":2734,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,181],"tags":[429,411,430,290,378,203,218,221,391,372],"class_list":["post-2733","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc","category-tin-tuc-cong-nghe","tag-filterfine","tag-filterfine-viet-nam","tag-fvn","tag-giam-sat-phong-sach","tag-kiemtrachatluong","tag-lighthouse","tag-may-dem-tieu-phan-trong-khong-khi","tag-phong-sach","tag-thiet-bi-trong-phong-sach","tag-thietbiphongsach"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>WEBINAR LWS: Risk-Based Airborne Probe Placement for Sterile Manufacturing - C\u00d4NG TY TNHH C\u00d4NG NGH\u1ec6 FILTERFINE VI\u1ec6T NAM<\/title>\n<meta name=\"description\" content=\"Webinar h\u01b0\u1edbng 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