{"title":"Part 11 \u0026 Systems","description":"\u003cp\u003ePublications - Electronic Systems, 21 CFR Part 11, Annex 11\u003c\/p\u003e","products":[{"product_id":"part11withscopeapplication-htm","title":"21 CFR Part 11 with Scope \u0026 Application","description":"\u003cp\u003e\u003cstrong\u003e21 CFR Part 11 Electronic Records; Electronic Signatures\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"text-decoration: underline;\"\u003e\u003cb\u003eUS FDA Title 21 CFR Part 11 Pocket Guide\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eElectronic Records; Electronic Signatures\u003c\/li\u003e\n\u003cli\u003eScope and Application - August 2003\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThis regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records.\u003c\/p\u003e\n\u003cp\u003eThis part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.\u003c\/p\u003e\n\u003cp\u003eAlso includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":46993528357099,"sku":"978-1-933734-00-2","price":5.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/21Part11ScopeandApp-1_0bd161fa-06c5-437c-b7be-8a0bfb57bb48.jpg?v=1761487713"},{"product_id":"part11w210211w820-htm","title":"21 CFR 11, 210\/211, 820 QMSR - Electronic Records with Drug and Device GMPs","description":"\u003cp\u003e\u003cb\u003eUS FDA Title 21 CFR PARTS 11, 210\/211 and 820 QMSR Standard GMP Pocket Guide\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e3 popular regulations in an easy to carry pocket handbook.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eUS FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures with Scope and Application - August 2003\u003c\/li\u003e\n\u003cli\u003e21 CFR Parts 210\/211 Drug GMPs\u003c\/li\u003e\n\u003cli\u003e21 CFR Part 820 - Quality Management System Regulations (QMSR) 2026 with ISO 13485 Reference Table\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThis regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. 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text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!-- [if !supportLineBreakNewLine]--\u003e\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360778010859,"sku":"T-01-INTL","price":7995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"training-2-day-onsite-all-inclusive-u-s","title":"Training - 2 Day Onsite All Inclusive - U.S.","description":"\u003cp style=\"margin-left: 48.75pt; text-indent: -40.5pt;\" class=\"MsoNormal\"\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003e\u003cu\u003eTraining Scope\u003c\/u\u003e\u003c\/b\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e – I\u003c\/span\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003enclude 10 sets (Additional Sets available at $50.00 per set):\u003c\/b\u003e\u003c\/p\u003e\n\u003cp style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\" class=\"MsoNormal\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eBinder Workbooks – 300+ slide workbook\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\" class=\"MsoNormal\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eChoice of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli style=\"list-style-type: none;\"\u003e\n\u003cul\u003e\n\u003cli style=\"text-indent: -0.25in;\" class=\"MsoNormal\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eGMP International Master Handbook \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli style=\"text-indent: -0.25in;\" class=\"MsoNormal\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eMedical Device Master Reference Guide\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli style=\"text-indent: -0.25in;\" class=\"MsoNormal\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\" class=\"MsoNormal\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ca href=\"https:\/\/gmppublications.com\/products\/training-materials\" title=\"Training Sets\"\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eFor additional training sets click on \u003cspan\u003ehttps:\/\/gmppublications.com\/products\/training-materials\u003c\/span\u003e\u003c\/span\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003eTo save on Credit Card charges, bank wire your payment to:\u003c\/p\u003e\n\u003cp style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\" class=\"MsoNormal\"\u003eBank: WSFS\u003cbr\u003eBank Address: 1484 U.S. Rt. 206, Tabernacle, NJ 08088\u003cbr\u003eBank Tel: 609-268-5993\u003cbr\u003eAccount name: GMP Publications\u003cbr\u003eAccount No: 2801578689\u003cbr\u003eRouting: 031100102\u003cbr\u003eSwift Code: WSFCUS33\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360778600683,"sku":"T-02-US","price":6995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"training-3-day-onsite-all-inclusive-u-s-copy","title":"Training - 3 Day Onsite All Inclusive - U.S.","description":"\u003cp class=\"MsoNormal\" style=\"margin-left: 48.75pt; text-indent: -40.5pt;\"\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003e\u003cu\u003eTraining Scope\u003c\/u\u003e\u003c\/b\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e – I\u003c\/span\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003enclude 10 sets (Additional Sets available at $50.00 per set):\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eBinder Workbooks – 300+ slide workbook\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eChoice of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli style=\"list-style-type: none;\"\u003e\n\u003cul\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eGMP International Master Handbook \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eMedical Device Master Reference Guide\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ca title=\"Training Sets\" href=\"https:\/\/gmppublications.com\/products\/training-materials\"\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eFor additional training sets click on \u003cspan\u003ehttps:\/\/gmppublications.com\/products\/training-materials\u003c\/span\u003e\u003c\/span\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003eOr Bank wire your payment to:\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003eBank: WSFS\u003cbr\u003eBank Address: 1484 U.S. Rt. 206, Tabernacle, NJ 08088\u003cbr\u003eBank Tel: 609-268-5993\u003cbr\u003eAccount name: GMP Publications\u003cbr\u003eAccount No: 2801578689\u003cbr\u003eRouting: 031100102\u003cbr\u003eSwift Code: WSFCUS33\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360778961131,"sku":"T-03-US","price":7995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"training-2-day-onsite-all-inclusive-international","title":"Training - 2 Day Onsite All Inclusive - International","description":"\u003cp class=\"MsoNormal\" style=\"margin-left: 48.75pt; text-indent: -40.5pt;\"\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003e\u003cu\u003eTraining Scope\u003c\/u\u003e\u003c\/b\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e – I\u003c\/span\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003enclude 10 sets (Additional Sets available at $50.00 per set):\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eBinder Workbooks – 300+ slide workbook\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eChoice of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eGMP International Master Handbook \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eMedical Device Master Reference Guide\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!-- [if !supportLineBreakNewLine]--\u003e\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360779747563,"sku":"T-02-INTL","price":8995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"training-4-day-onsite-all-inclusive-international","title":"Training - 3 Day Onsite All Inclusive - International","description":"\u003cp class=\"MsoNormal\" style=\"margin-left: 48.75pt; text-indent: -40.5pt;\"\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003e\u003cu\u003eTraining Scope\u003c\/u\u003e\u003c\/b\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e – I\u003c\/span\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003enclude 10 sets (Additional Sets available at $50.00 per set):\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eBinder Workbooks – 300+ slide workbook\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eChoice of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eGMP International Master Handbook \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eMedical Device Master Reference Guide\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 80.25pt; text-indent: -.25in; mso-list: l0 level2 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!-- [if !supportLineBreakNewLine]--\u003e\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360779845867,"sku":"T-03-INTL","price":9995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"training-1-day-onsite-all-inclusive-u-s-1","title":"Training - 1 Day Onsite All Inclusive - U.S.","description":"\u003cp class=\"MsoNormal\" style=\"margin-left: 48.75pt; text-indent: -40.5pt;\"\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003e\u003cu\u003eTraining Scope\u003c\/u\u003e\u003c\/b\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e – I\u003c\/span\u003e\u003cb style=\"mso-bidi-font-weight: normal;\"\u003enclude 10 sets (Additional Sets available at $50.00 per set):\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eBinder Workbooks – 300+ slide workbook\u003c\/span\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eChoice of:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli style=\"list-style-type: none;\"\u003e\n\u003cul\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eGMP International Master Handbook \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eMedical Device Master Reference Guide\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli class=\"MsoNormal\" style=\"text-indent: -0.25in;\"\u003e\n\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: 'Courier New'; mso-fareast-font-family: 'Courier New'; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003eo\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCombination Product Master Handbook\u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003e\u003c!-- [if !supportLists]--\u003e\u003cspan style=\"font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; mso-bidi-font-weight: bold;\"\u003e\u003cspan style=\"mso-list: Ignore;\"\u003e·\u003cspan style=\"font: 7.0pt 'Times New Roman';\"\u003e         \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c!--[endif]--\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eCertificate of Attendance\u003cbr style=\"mso-special-character: line-break;\"\u003e\u003c!--[endif]--\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ca title=\"Training Sets\" href=\"https:\/\/gmppublications.com\/products\/training-materials\"\u003e\u003cspan style=\"mso-bidi-font-weight: bold;\"\u003eFor additional training sets click on \u003cspan\u003ehttps:\/\/gmppublications.com\/products\/training-materials\u003c\/span\u003e\u003c\/span\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003eTo save on Credit Card charges, bank wire your payment to:\u003c\/p\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-left: 44.25pt; text-indent: -.25in; mso-list: l0 level1 lfo1;\"\u003eBank: WSFS\u003cbr\u003eBank Address: 1484 U.S. Rt. 206, Tabernacle, NJ 08088\u003cbr\u003eBank Tel: 609-268-5993\u003cbr\u003eAccount name: GMP Publications\u003cbr\u003eAccount No: 2801578689\u003cbr\u003eRouting: 031100102\u003cbr\u003eSwift Code: WSFCUS33\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47360781910251,"sku":"T-01-US","price":5995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCLogo8White.jpg?v=1768993679"},{"product_id":"audit-and-training-1-day-onsite-all-inclusive-audit-with-1-day-training-international","title":"Audit and Training - 1 Day Onsite All-Inclusive Audit with 1 Day Training - International","description":"\u003cp\u003eTurnkey Audits \u0026amp; Training includes Airfare, Travel Rates, Hotel, Expenses \u0026amp; Reports (1 Draft \u0026amp; 1 Final).\u003cbr\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eGMP Audits - Drug, APIs, Excipients (DS\/DP)\u003c\/li\u003e\n\u003cli\u003eMedical Devices - Part 820 QMSR \/ ISO 13485\u003c\/li\u003e\n\u003cli\u003eSupplier Audits, CMOs, CDMOs, CROs, Systems\u003c\/li\u003e\n\u003cli\u003eLaboratory Audits - GLP - GCLP, Part 58\/OECD\u003c\/li\u003e\n\u003cli\u003e21 CFR Part 11 Compliance \u0026amp; Validation Audits\u003c\/li\u003e\n\u003cli\u003eCosmetics GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eDietary Supplement GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eClinical, CROs, GCLP, Investigator Sites Audits\u003c\/li\u003e\n\u003cli\u003e503b Outsourced Facility Qualifications\u003c\/li\u003e\n\u003cli\u003eAcquisitions \u0026amp; Compliance Audits\u003c\/li\u003e\n\u003cli\u003eFinancial Forensic Audits\u003c\/li\u003e\n\u003cli\u003eMock FDA, EU, NMPA, PMDA, Canada \u0026amp; WHO Audits\u003c\/li\u003e\n\u003cli\u003eRetail Market Supplier GMP Certificates\u003c\/li\u003e\n\u003cli\u003eCombination Devices \u0026amp; MDSAP Audits\u003c\/li\u003e\n\u003cli\u003eValidation Audits - Process, Equipment, Software\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":47361640235243,"sku":"A01-T01-INTL","price":9990.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/TAG-GMPBC.jpg?v=1768996733"},{"product_id":"audit-and-training-2-day-onsite-all-inclusive-audit-with-1-day-training-international","title":"Audit and Training - 2 Day Onsite All-Inclusive Audit with 1 Day Training - International","description":"\u003cp\u003eTurnkey Audits \u0026amp; Training includes Airfare, Travel Rates, Hotel, Expenses \u0026amp; Reports (1 Draft \u0026amp; 1 Final).\u003cbr\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eGMP Audits - Drug, APIs, Excipients (DS\/DP)\u003c\/li\u003e\n\u003cli\u003eMedical Devices - Part 820 QMSR \/ ISO 13485\u003c\/li\u003e\n\u003cli\u003eSupplier Audits, CMOs, CDMOs, CROs, Systems\u003c\/li\u003e\n\u003cli\u003eLaboratory Audits - GLP - GCLP, Part 58\/OECD\u003c\/li\u003e\n\u003cli\u003e21 CFR Part 11 Compliance \u0026amp; Validation Audits\u003c\/li\u003e\n\u003cli\u003eCosmetics GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eDietary Supplement GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eClinical, CROs, GCLP, Investigator Sites Audits\u003c\/li\u003e\n\u003cli\u003e503b Outsourced Facility Qualifications\u003c\/li\u003e\n\u003cli\u003eAcquisitions \u0026amp; Compliance Audits\u003c\/li\u003e\n\u003cli\u003eFinancial Forensic Audits\u003c\/li\u003e\n\u003cli\u003eMock FDA, EU, NMPA, PMDA, Canada \u0026amp; 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Training includes Airfare, Travel Rates, Hotel, Expenses \u0026amp; Reports (1 Draft \u0026amp; 1 Final).\u003cbr\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eGMP Audits - Drug, APIs, Excipients (DS\/DP)\u003c\/li\u003e\n\u003cli\u003eMedical Devices - Part 820 QMSR \/ ISO 13485\u003c\/li\u003e\n\u003cli\u003eSupplier Audits, CMOs, CDMOs, CROs, Systems\u003c\/li\u003e\n\u003cli\u003eLaboratory Audits - GLP - GCLP, Part 58\/OECD\u003c\/li\u003e\n\u003cli\u003e21 CFR Part 11 Compliance \u0026amp; Validation Audits\u003c\/li\u003e\n\u003cli\u003eCosmetics GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eDietary Supplement GMP Audits \u0026amp; Certificates\u003c\/li\u003e\n\u003cli\u003eClinical, CROs, GCLP, Investigator Sites Audits\u003c\/li\u003e\n\u003cli\u003e503b Outsourced Facility Qualifications\u003c\/li\u003e\n\u003cli\u003eAcquisitions \u0026amp; Compliance Audits\u003c\/li\u003e\n\u003cli\u003eFinancial Forensic Audits\u003c\/li\u003e\n\u003cli\u003eMock FDA, EU, NMPA, PMDA, Canada \u0026amp; 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Includes US, EU, ICH, Canadian, Chinese and Japanese GMPs!\u003c\/h4\u003e\n\u003cdiv\u003e\n\u003cp\u003e\u003cstrong\u003eIncludes:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eUS FDA Title 21 CFR Parts:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e- Part 11 Electronic Records; Electronic Signatures\u003cbr\u003e- Part 11 Scope and Application 2003\u003cbr\u003e- Part 11 - Auditor's Check List\u003cbr\u003e- Part 58 - Good Laboratory Practice\u003cbr\u003e- Part 111 - Dietary Supplements GMPs\u003cbr\u003e- Parts 210\/211 Drug GMPs\u003cbr\u003e- Parts 210\/211 Drug GMPs - Auditor's Check List\u003cbr\u003e- Part 820 Quality Management Systems Regulations QMSR 2026\u003cbr\u003e- Part 820 Quality Systems Regulations (Legacy)\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eGuidance:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e- ICH Q7 - Active Pharmaceutical Ingredients (APIs)\u003cbr\u003e- ICH Q7 - Auditor's Check List\u003cbr\u003e- ICH Q8(R2) - Pharmaceutical Development\u003cbr\u003e- ICH Q9(R1) - Quality Risk Management\u003cbr\u003e- ICH Q10 - Pharmaceutical Quality System\u003cbr\u003e- EU GMPs Chapter 1 - 9\u003cbr\u003e- Canadian GMPs Edition GUI-0001 - July 2020\u003cbr\u003e- Japanese GMPs\u003cbr\u003e- Chinese GMPs Decree 79 English\u003c\/p\u003e\n- - - - - - - - - - - - - - - - - - - - - - -\u003c\/div\u003e","brand":"GMP Publications","offers":[{"title":"Default Title","offer_id":48038975799531,"sku":"978-1-935131-37-3","price":24.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPInternMaster-C-260401_81fc5a02-d3b6-4cb0-bcdd-fc201fe2c379.png?v=1773866314"},{"product_id":"master-reference-desk-set-pharmaceutical-medical-device","title":"Master Reference Desk Set - Drug, Dietary \u0026 Medical Device","description":"\u003ch3\u003e\u003cspan style=\"text-decoration: underline; color: rgb(43, 0, 255);\"\u003e\u003cstrong\u003e\u003cspan style=\"color: rgb(255, 0, 0); text-decoration: underline;\"\u003eMaster Reference Desk Set - Drug, Dietary \u0026amp; Medical Device - Over 1900 pages of Regulations, Guidance \u0026amp; Audit Checklists!\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch3\u003e\u003cspan style=\"text-decoration: underline; color: rgb(43, 0, 255);\"\u003e\u003cstrong\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch3\u003e\u003cspan style=\"text-decoration: underline; color: rgb(43, 0, 255);\"\u003e\u003cstrong\u003ePharmaceutical and Dietary Supplement Master Regulations:\u003c\/strong\u003e\u003c\/span\u003e\u003c\/h3\u003e\n\u003ch4\u003eOver 950 pages of GMP guidance and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian, Chinese and Japanese GMPs!\u003c\/h4\u003e\n\u003cdiv\u003e\n\u003cp\u003e\u003cstrong\u003eIncludes:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eUS FDA Title 21 CFR Parts:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e- Part 11 Electronic Records; Electronic Signatures\u003cbr\u003e- Part 11 Scope and Application 2003\u003cbr\u003e- Part 11 - Auditor's Check List\u003cbr\u003e- Part 58 - Good Laboratory Practice\u003cbr\u003e- Part 111 - Dietary Supplements GMPs\u003cbr\u003e- Parts 210\/211 Drug GMPs\u003cbr\u003e- Parts 210\/211 Drug GMPs - Auditor's Check List\u003cbr\u003e- Part 820 Quality Management Systems Regulations QMSR 2026\u003cbr\u003e- Part 820 Quality Systems Regulations (Legacy)\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eGuidance:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eICH Q7 - Active Pharmaceutical Ingredients (APIs)\u003cbr\u003e- ICH Q7 - Auditor's Check List\u003cbr\u003e- ICH Q8(R2) - Pharmaceutical Development\u003cbr\u003e- ICH Q9(R1) - Quality Risk Management\u003cbr\u003e- ICH Q10 - Pharmaceutical Quality System\u003cbr\u003e- EU GMPs Chapter 1 - 9\u003cbr\u003e- Canadian GMPs Edition GUI-0001 - July 2020\u003cbr\u003e- Japanese GMPs\u003cbr\u003e- Chinese GMPs Decree 79 English\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003e\u003cspan style=\"text-decoration: underline; color: rgb(43, 0, 255);\"\u003e\u003cstrong\u003eMedical Device Master Regulations\u003c\/strong\u003e\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp\u003eOver 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Master Manual\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eUS FDA Title 21 CFR Parts:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e- Part 11 - Electronic Records\/Electronic Signatures (ERES)\u003cbr\u003e- Part 801 - Labeling - Medical Device\u003cbr\u003e- Part 803 - Medical Device Reporting\u003cbr\u003e- Part 806 - Reports of Corrections and Removal\u003cbr\u003e- Part 807 - Establishment Regulation and Device Listing for Manufacturers\u003cbr\u003e- Part 809 - In-Vitro Diagnostic Products\u003cbr\u003e- Part 810 - Medical Device Recall Authority\u003cbr\u003e- Part 812 - Investigational Device Exemptions\u003cbr\u003e- Part 814 - Premarket Approval of Medical Device\u003cbr\u003e- Part 820 - Quality Management Systems Regulations 2026\u003cbr\u003e- Part 821 - Medical Device Tracking Requirements\u003cbr\u003e- Part 830 - Unique Device Identification\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eGuidance:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cspan\u003e\u003c\/span\u003e\u003cu\u003e\u003cstrong\u003eAdded\u003c\/strong\u003e\u003c\/u\u003e\u003cspan\u003e \u003c\/span\u003e- 820 QMSR Checklist with ISO 13485 Reference\u003cbr\u003e- Medical Device QSIT Manual\u003cbr\u003e- PMA Premarket Approval and 510 (k) Guidance\u003cbr\u003e- Inspection of Medical Device Manufacturers 7382.850\u003cbr\u003e- EU 2017\/745 Medical Device Regulation\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e","brand":"GMP","offers":[{"title":"Default Title","offer_id":48205344899307,"sku":null,"price":45.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/DeskReference_021a6882-36a2-4eb3-be5e-c457886a219f.jpg?v=1777990209"},{"product_id":"8-hour-monthly-gmp-training-digital-certificate-gmp-handbook-e-workbook","title":"FREE* 8-Hour GMP QMS Training - Select Month","description":"\u003ctable width=\"100%\" border=\"1\" cellspacing=\"2\" cellpadding=\"2\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003ch3\u003e\u003cstrong\u003eGMP Boot Camps, GMP Publications \u0026amp; The Auditing Group, offering Free\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e*\u003c\/span\u003e Monthly GMP Training includes \u003cspan style=\"color: rgb(255, 42, 0);\"\u003eRegistration\u003c\/span\u003e Fee, \u003cspan style=\"color: rgb(255, 42, 0);\"\u003e\u003cspan style=\"text-decoration: underline;\"\u003eDigital\u003c\/span\u003e Certificate\u003c\/span\u003e \u0026amp; \u003cspan style=\"color: rgb(255, 42, 0);\"\u003ee-Workbook (\u003ca title=\"GMP Boot Camp Brochure\" href=\"https:\/\/www.gmpbootcamps.com\/_files\/ugd\/889bfb_2b3b698e45f548e2a7482d19716463b9.pdf\"\u003eDownload Brochure\u003c\/a\u003e)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e* The Instructor's Time is Free - Registration, Certificate, e-Workbook is $29.95. The fee prevents 'No-Shows' registrations.\u003c\/span\u003e\n\u003cp\u003e\u003cstrong\u003eQuantity Discounts Automatically Apply:\u003cbr\u003e\u003cspan style=\"text-decoration: underline;\"\u003e5 Seat - 5%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e10 Seat - 10%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e25 Seat - 15%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e50 Seat - 20%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e100 Seat - 25%\u003c\/span\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNOTE: Each person must register with a unique email address to get credit. \u003cbr\u003efor more information go to \u003ca title=\"GMP Boot Camp website\" href=\"https:\/\/www.gmpbootcamps.com\" rel=\"noopener\" target=\"_blank\"\u003eGMP Boot Camp website Terms\u003c\/a\u003e. \u003cspan style=\"font-size: 0.875rem;\"\u003e See \u003c\/span\u003e\u003ca href=\"http:\/\/www.gmpbootcamps.com\" style=\"font-size: 0.875rem;\"\u003ewww.gmpbootcamps.com\u003c\/a\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003e for Free GMP QMS Training Schedule.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCheck dates at www.gmpbootcamps.com\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eGMP Basics 101 (See Agenda Below)\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures\u003c\/strong\u003e with Scope and Application 2003 - FDA Interpretation of Part 11.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Parts 210\/211 Good Manufacturing Practices\u003c\/strong\u003e - The regulations containing the minimum CGMPs for methods, facilities or controls to be used for manufacture, processing, packing, or holding of a drug product.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Part 820 Quality Management Systems Regulation\u003c\/strong\u003e The controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e*The $29.95 Registration Fee includes, Registration, e-Workbook \u0026amp; e-Certificate and to prevents 'No-Shows' registrants. \u003cbr\u003eThe Webinar SME's Time is FREE. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e(See: http:\/\/www.gmpbootcamps.com). \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003eIf you have a discount code, apply discount code below. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003eAgenda: GMP 101 Basics: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Risk Management \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e The GMP Focus \u0026amp; The GMP Lifestyle, \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Roles \u0026amp; Responsibilities • Agency Inspections \u0026amp; Observations \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Quality Terminology \u0026amp; Quality Controls The QMS Basics: \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e QMS Basics \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e CAPA - Corrective \u0026amp; Preventive Actions; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Non-Conformance - Materials; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Change Control - Documentation, Engineering, Production \u0026amp; Distribution; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Deviations - Deviation Management Essentials; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Out of Specifications \/ Out of Trend - Management of OOS \u0026amp; OOT; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Complaints - Receipt, Assessments \u0026amp; Remediation\/Resolution; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Recalls - The Plan \u0026amp; Process; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Product Traceability; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Audit - Internal, Agency, Customers \u0026amp; External Audits; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Vendors, Suppliers \u0026amp; Contractors - Quality Agreements; \u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003eThe Meetings - Management \u0026amp; Quality Meetings; GMP 11 General Orders: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003col\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Write Procedures; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Follow Procedures; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Documentation; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Validation; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Build Facilities; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Maintaining Facilities; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Competency; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Good Housekeeping Practices; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Control for Quality; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Audit for Compliance; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Prepare for Battle - Recall \u0026amp; Traceability Audits; \u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003e21 CFR Part 11 Electronic Records; Electronic Signatures: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• Basic Overview; Definitions \u0026amp; Classifications; \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• Part 11.10 Sections a) - k) \u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e (a) Validation \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e (b) Copies of Records \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e(c\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Protection of Records \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(d)\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Limit Access \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Audit Trails \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(f\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Forced Steps \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(g)\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Authority Checks \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(h) \u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Device Qualifications \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(i) \u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Training \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003ej) Procedures \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003ek) Documentation \u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• ALCOA and GAMP \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• MS Excel \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e*Conditions: Must meet 7-hour min. to receive Certificates. 'Eye's On' verification in place to ensure registrants viewed Webinars. Attendees must login using unique email address to obtain a certificate. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003eNOTE: REGISTRAT NAME DOES NOT HAVE TO MATCH NAME ON CREDIT CARD!\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"January","offer_id":48275353567467,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"February","offer_id":48417842692331,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"March","offer_id":48275353600235,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"April","offer_id":48275353633003,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"May","offer_id":48275353665771,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"June","offer_id":48275353698539,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"July","offer_id":48417913405675,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"August","offer_id":48275353731307,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"September","offer_id":48275353764075,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"October","offer_id":48275353796843,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"November","offer_id":48275353829611,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true},{"title":"December","offer_id":48275353862379,"sku":null,"price":29.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/GMPBCBanner_QR-August2026.png?v=1783428492"},{"product_id":"free-8-hour-monthly-gmp-qms-training-handbook-select-month","title":"FREE* 8-Hour GMP QMS Training, Paper Certificate \u0026 Handbook - Select Month","description":"\u003ctable width=\"100%\" border=\"1\" cellspacing=\"2\" cellpadding=\"2\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003ch3\u003e\u003cstrong\u003eGMP Boot Camps, GMP Publications \u0026amp; The Auditing Group, offering Free\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e*\u003c\/span\u003e Monthly GMP Training includes \u003cspan style=\"color: rgb(255, 42, 0);\"\u003eRegistration\u003c\/span\u003e Fee, \u003cspan style=\"text-decoration: underline;\"\u003e\u003cspan style=\"color: rgb(255, 42, 0); text-decoration: underline;\"\u003ePaper Sealed Certificate\u003c\/span\u003e\u003c\/span\u003e \u0026amp; \u003cspan style=\"color: rgb(255, 42, 0);\"\u003ee-Workbook, and \u003cspan style=\"text-decoration: underline;\"\u003ePaper Handbook\u003c\/span\u003e (\u003ca title=\"GMP Boot Camp Brochure\" href=\"https:\/\/www.gmpbootcamps.com\/_files\/ugd\/889bfb_2b3b698e45f548e2a7482d19716463b9.pdf\"\u003eDownload Brochure\u003c\/a\u003e)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e* The Instructor's Time is Free - Registration, Certificate, Workbook is $39.95. The fee prevents 'No-Shows' registrations.\u003c\/span\u003e\n\u003cp\u003e\u003cstrong\u003eQuantity Discounts Automatically Apply:\u003cbr\u003e\u003cspan style=\"text-decoration: underline;\"\u003e5 Seat - 5%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e10 Seat - 10%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e25 Seat - 15%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e50 Seat - 20%\u003c\/span\u003e   \u003cspan style=\"text-decoration: underline;\"\u003e100 Seat - 25%\u003c\/span\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNOTE: Each person must register with a unique email address to get credit. \u003cbr\u003efor more information go to \u003ca title=\"GMP Boot Camp website\" href=\"https:\/\/www.gmpbootcamps.com\" rel=\"noopener\" target=\"_blank\"\u003eGMP Boot Camp website Terms\u003c\/a\u003e. \u003cspan style=\"font-size: 0.875rem;\"\u003e See \u003c\/span\u003e\u003ca href=\"http:\/\/www.gmpbootcamps.com\" style=\"font-size: 0.875rem;\"\u003ewww.gmpbootcamps.com\u003c\/a\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003e for Free GMP QMS Training Schedule.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCheck dates at www.gmpbootcamps.com\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eGMP Basics 101 (See Agenda Below)\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures\u003c\/strong\u003e with Scope and Application 2003 - FDA Interpretation of Part 11.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Parts 210\/211 Good Manufacturing Practices\u003c\/strong\u003e - The regulations containing the minimum CGMPs for methods, facilities or controls to be used for manufacture, processing, packing, or holding of a drug product.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS FDA Title 21 CFR Part 820 Quality Management Systems Regulation\u003c\/strong\u003e The controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e*The $29.95 Registration Fee includes, Registration, e-Workbook \u0026amp; e-Certificate and to prevents 'No-Shows' registrants. \u003cbr\u003eThe Webinar SME's Time is FREE. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e(See: http:\/\/www.gmpbootcamps.com). \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003eIf you have a discount code, apply discount code below. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003eAgenda: GMP 101 Basics: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Risk Management \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e The GMP Focus \u0026amp; The GMP Lifestyle, \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Roles \u0026amp; Responsibilities • Agency Inspections \u0026amp; Observations \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Quality Terminology \u0026amp; Quality Controls The QMS Basics: \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e QMS Basics \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e CAPA - Corrective \u0026amp; Preventive Actions; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Non-Conformance - Materials; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Change Control - Documentation, Engineering, Production \u0026amp; Distribution; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Deviations - Deviation Management Essentials; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Out of Specifications \/ Out of Trend - Management of OOS \u0026amp; OOT; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Complaints - Receipt, Assessments \u0026amp; Remediation\/Resolution; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Recalls - The Plan \u0026amp; Process; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Product Traceability; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Audit - Internal, Agency, Customers \u0026amp; External Audits; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Vendors, Suppliers \u0026amp; Contractors - Quality Agreements; \u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003eThe Meetings - Management \u0026amp; Quality Meetings; GMP 11 General Orders: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003col\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Write Procedures; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Follow Procedures; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Documentation; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Validation; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Build Facilities; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Maintaining Facilities; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Competency; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Good Housekeeping Practices; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Control for Quality; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Audit for Compliance; \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Prepare for Battle - Recall \u0026amp; Traceability Audits; \u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e\u003cstrong\u003e21 CFR Part 11 Electronic Records; Electronic Signatures: \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• Basic Overview; Definitions \u0026amp; Classifications; \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• Part 11.10 Sections a) - k) \u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e (a) Validation \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e (b) Copies of Records \u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e(c\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Protection of Records \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(d)\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Limit Access \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Audit Trails \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(f\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e) Forced Steps \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(g)\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Authority Checks \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(h) \u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Device Qualifications \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(i) \u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e Training \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003ej) Procedures \u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli\u003e(\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003ek) Documentation \u003c\/span\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• ALCOA and GAMP \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e• MS Excel \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003e*Conditions: Must meet 7-hour min. to receive Certificates. 'Eye's On' verification in place to ensure registrants viewed Webinars. Attendees must login using unique email address to obtain a certificate. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan data-bind=\"expander:{'expandText': moreButtonText(), 'userCollapseText': lessButtonText(), 'text':getWebinarInfo().description}\"\u003eNOTE: REGISTRAT NAME DOES NOT HAVE TO MATCH NAME ON CREDIT CARD!\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"GMP Publications","offers":[{"title":"January","offer_id":48470907977963,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"February","offer_id":48470908010731,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"March","offer_id":48470908043499,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"April","offer_id":48470908076267,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"May","offer_id":48470908109035,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"June","offer_id":48470908141803,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"July","offer_id":48470908174571,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"August","offer_id":48470908207339,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"September","offer_id":48470908240107,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"October","offer_id":48470908272875,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"November","offer_id":48470908305643,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true},{"title":"December","offer_id":48470908338411,"sku":null,"price":39.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/1498\/5963\/files\/TrainingCertExample.jpg?v=1780228822"}],"url":"https:\/\/gmppublications.com\/collections\/publications-electronic-systems.oembed?page=2","provider":"GMP","version":"1.0","type":"link"}