{"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","url":"https:\/\/gmppublications.com\/products\/master-reference-desk-set-pharmaceutical-medical-device","provider":"GMP","version":"1.0","type":"link"}