{"id":12093,"date":"2020-10-03T16:03:26","date_gmt":"2020-10-03T08:03:26","guid":{"rendered":"https:\/\/www.sqi.org.sg\/?post_type=lp_course&#038;p=12093"},"modified":"2025-12-24T18:35:05","modified_gmt":"2025-12-24T10:35:05","slug":"interpretation-application-21-cfr-820","status":"publish","type":"lp_course","link":"https:\/\/www.staging.sqi.org.sg\/staging\/courses\/interpretation-application-21-cfr-820\/","title":{"rendered":"INTERPRETATION &#038; APPLICATION OF 21 CFR 820"},"content":{"rendered":"<h4>Introduction<\/h4>\n<p><strong>Title 21: Food and Drug<\/strong><br \/>\n<strong>Part 820: Quality System Regulation<\/strong><\/p>\n<p style=\"text-align: justify;\">Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective in compliance.<\/p>\n<h4>Learning Objectives<\/h4>\n<p>This program is designed to equip the participants with the practical knowledge to interpret 21 CFR 820 with a view to establish and integrate the Quality System Regulation into the ISO 13485:2016 Quality System Documentation effectively for the manufacture of Medical Devices.<\/p>\n<h4>Duration<\/h4>\n<p>2 days | 9am \u2013 5pm | 14 hours<\/p>\n<h4>Who Should Attend<\/h4>\n<p>This program is designed for R&amp;D, Technical, QC\/QA\/RA, Engineering and Production personnel who are involved in implementing 21 CFR Part 820 in their manufacturing environment.<\/p>\n<h4>Entry Requirement<\/h4>\n<p>Basic understanding on ISO 9001:2015 and\/or ISO 13485:2016 Quality System Requirements is preferred.<\/p>\n<h4>Course Fees<\/h4>\n<p data-pm-slice=\"1 1 []\">Member Fee: S$1,076.92<br \/>\nNon-Member Fee: S$1,194.64<\/p>\n<p><small><em>All fees stated are inclusive of Registration Fee and 9% GST.<\/em><\/small><\/p>\n<h4>Award of Certificate<\/h4>\n<p>Certificate of Completion will be issued to participants who have attended at least 75% of the course.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Introduction Title 21: Food and Drug Part 820: Quality System Regulation Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished devices&#8230;<\/p>\n","protected":false},"author":1,"featured_media":14523,"comment_status":"open","ping_status":"closed","template":"","course_category":[69],"course_tag":[76],"class_list":["post-12093","lp_course","type-lp_course","status-publish","has-post-thumbnail","hentry","course_category-iso-standards","course_tag-iso_standards","pmpro-has-access","course"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>INTERPRETATION &amp; APPLICATION OF 21 CFR 820 - Singapore Quality Institute<\/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:\/\/www.staging.sqi.org.sg\/staging\/courses\/interpretation-application-21-cfr-820\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INTERPRETATION &amp; APPLICATION OF 21 CFR 820 - Singapore Quality Institute\" \/>\n<meta property=\"og:description\" content=\"Introduction Title 21: Food and Drug Part 820: Quality System Regulation Current Good Manufacturing Practice (cGMP) requirements are set forth in this quality system regulation. 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