{"id":141,"date":"2013-05-14T13:08:23","date_gmt":"2013-05-14T19:08:23","guid":{"rendered":"https:\/\/marianboardley.com\/blog\/?p=141"},"modified":"2014-05-06T00:54:54","modified_gmt":"2014-05-06T00:54:54","slug":"ahpas-cgmp-compliance-series-best-practices-for-cgmp-change-control","status":"publish","type":"post","link":"https:\/\/marianboardley.com\/blog\/ahpas-cgmp-compliance-series-best-practices-for-cgmp-change-control\/","title":{"rendered":"AHPA&#8217;s cGMP Compliance Series: cGMP  Change Control"},"content":{"rendered":"<table width=\"657\" border=\"0\" cellspacing=\"5\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"100%\"><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">\n<table tabindex=\"0\" width=\"180\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\" width=\"100%\">\n<table width=\"210\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>\n<p style=\"text-align: left;\">Thursday, June 20, 2013<\/p>\n<p>1- 3\u00a0p.m. EDT<\/p>\n<p><b>COST: <\/b><\/p>\n<p>Member: $195 Nonmember: $495<\/p>\n<p><strong>PRESENTERS:<\/strong><\/p>\n<p><strong>Marian Boardley, <\/strong><b>Marian Boardley Consulting<\/b><\/p>\n<p><strong><\/strong><strong>Staci Eisner, <\/strong><b>Cortex Scientific Botanicals<\/b><\/p>\n<p><strong>Stefan Gafner, <\/strong><b>Tom&#8217;s of Maine<\/b><\/p>\n<p><strong>Anthony Young, <\/strong><b>Kleinfeld, Kaplan &amp; Becker and AHPA General Counsel<\/b><\/p>\n<p><b>\u00a0\u00a0<\/b><\/p>\n<p><b>\u00a0\u00a0<\/b><\/p>\n<p><b>Who should attend: <\/b><strong>QA\/QC personnel, Lab managers, technicians, Operations, R&amp;D staff, New product development, and formulation personnel<\/strong><\/p>\n<p>Register today!<\/p>\n<p><b>AHPA<\/b><\/p>\n<p><b>8630 Fenton St., <\/b><\/p>\n<p><b>Ste. 918<\/b><\/p>\n<p><b>Silver Spring, <\/b><\/p>\n<p><b>MD 20910<\/b><\/p>\n<p><a href=\"http:\/\/r20.rs6.net\/tn.jsp?e=001mm9kJ8-yY9TTycf97BI9t9ciCh6Pm1t5ezJgBOD4R3H5mWbgPUrG596qzNHrkFRB5GTuLrhMkBe2CF36kLqHgMYuHaI_MZtaOpEvxHGnSaRJYk2BsW3SsA==\" target=\"_blank\" shape=\"rect\"><b>www.ahpa.org<\/b><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<td valign=\"top\">\n<table tabindex=\"0\" width=\"100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\" width=\"100%\">\n<table width=\"449\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>\n<p align=\"center\">\u00a0<strong>AHPA&#8217;s cGMP Compliance Series<\/strong><\/p>\n<p align=\"center\"><strong>presents<\/strong>\u00a0<strong><br \/>\n<\/strong><\/p>\n<p align=\"center\"><strong>&#8220;Best Practices&#8221; for cGMP <\/strong><\/p>\n<p align=\"center\"><strong>Change Control <\/strong><\/p>\n<p align=\"center\"><b>cGMP compliance information for <\/b><\/p>\n<p align=\"center\"><b>dietary supplement businesses<\/b><\/p>\n<p align=\"center\"><strong>Thursday, June 20, 2013<\/strong><\/p>\n<p style=\"text-align: center;\"><strong>1\u00a0&#8211;\u00a03 p.m. EDT<\/strong> <strong><\/strong><\/p>\n<p><em>Change control<\/em> is the process of implementing changes to cGMP-related operations and other business systems in a manner that ensures effectiveness and continued compliance.<\/p>\n<p>Change control can be applied to any business system, but in a cGMP context it can be applied to:<\/p>\n<ul>\n<li>Products (formulas, labels, etc.)<\/li>\n<li>Processes (manufacturing processes, test methods, etc.)<\/li>\n<li>Equipment and facilities (rooms, utility systems, process equipment, test equipment, instruments, utensils)<\/li>\n<li>Components and supplies, and vendors thereof<\/li>\n<li>Software, spreadsheets<\/li>\n<li>Personnel<\/li>\n<li>Documents (SOPs, MMRs, specification documents, forms, logs, etc.)<\/li>\n<\/ul>\n<p>Some changes are routine, such as training new personnel, updating a document, or replacing a simple test instrument such as a thermometer; these changes can be controlled through the establishment of an SOP for each circumstance.<br \/>\nOther changes are not routine, such as installing new major manufacturing equipment or significantly changing a manufacturing process, and need to be evaluated on a case-by-case basis.<\/p>\n<p>During this two-hour teleseminar, which includes a dedicated Q&amp;A session, learn from experts about how to implement and manage change control in compliance with 21 CFR 111.<\/p>\n<p>&nbsp;<\/p>\n<p align=\"center\"><strong><a href=\"http:\/\/r20.rs6.net\/tn.jsp?e=001mm9kJ8-yY9Sdd4tROlaoG-31REQQBuXEJYeu6nExEdoU6Wbkr-7phxxkipAWu5Sv2Z9mWMiwF2Eq5k_avrhW9Ea0YoOLUgL5nRNl2OHjeEw2waWT3vW-de9AE_IsIjFIwvn080il_Dl3cMTBCif-Ib3LVmfjXHLQeu83zuPq-TL6ZIJHmqPb0YDHLMMzdxdaCDDyfc0wHhU=\" target=\"_blank\" shape=\"rect\">CLICK HERE TO REGISTER<\/a><\/strong><\/p>\n<p align=\"center\"><b>(<\/b><b>or paste this link into your browser:<\/b><b><\/b><\/p>\n<p align=\"center\"><b><a href=\"http:\/\/r20.rs6.net\/tn.jsp?e=001mm9kJ8-yY9Sdd4tROlaoG-31REQQBuXEJYeu6nExEdoU6Wbkr-7phxxkipAWu5Sv2Z9mWMiwF2Eq5k_avrhW9Ea0YoOLUgL5nRNl2OHjeEw2waWT3vW-de9AE_IsIjFIwvn080il_Dl3cMTBCif-Ib3LVmfjXHLQeu83zuPq-TL6ZIJHmqPb0YDHLMMzdxdaCDDyfc0wHhU=\" target=\"_blank\" shape=\"rect\">https:\/\/connect.computility.com\/form\/index.php?id=bce42e4b4b2fd7dacf3eb6d1f3f8eff2<\/a><\/b><b><\/b><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\" width=\"100%\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"100%\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Thursday, June 20, 2013 1- 3\u00a0p.m. EDT COST: Member: $195 Nonmember: $495 PRESENTERS: Marian Boardley, Marian Boardley Consulting Staci Eisner, Cortex Scientific Botanicals Stefan Gafner, Tom&#8217;s of Maine Anthony Young, Kleinfeld, Kaplan &amp; Becker and AHPA General Counsel \u00a0\u00a0 \u00a0\u00a0 Who should attend: QA\/QC personnel, Lab managers, technicians, Operations, R&amp;D staff, New product development, and &hellip; <a href=\"https:\/\/marianboardley.com\/blog\/ahpas-cgmp-compliance-series-best-practices-for-cgmp-change-control\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">AHPA&#8217;s cGMP Compliance Series: cGMP  Change Control<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-141","post","type-post","status-publish","format-standard","hentry","category-meetings-and-seminars"],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p2Lzp2-2h","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/141","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/comments?post=141"}],"version-history":[{"count":1,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/141\/revisions"}],"predecessor-version":[{"id":233,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/141\/revisions\/233"}],"wp:attachment":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/media?parent=141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/categories?post=141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/tags?post=141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}