Dscsa Pharmaceutical Serialization Interoperability by Coreman Riley (4 results)
- Softcover
- Print on Demand
Seller: PBShop.store UK, Fairford, GLOS, United KingdomPBShop.store UK
Contact seller5-star sellerCondition: New
£ 138.89
£ 5.02 shippingShips from United Kingdom to U.S.A.Quantity: Over 20 available
PAP. Condition: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
- Softcover
- Print on Demand
Seller: PBShop.store US, Wood Dale, IL, U.S.A.PBShop.store US
Contact seller5-star sellerCondition: New
£ 150.17
Free ShippingShips within U.S.A.Quantity: Over 20 available
PAP. Condition: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
- Softcover
- Print on Demand
Seller: California Books, Miami, FL, U.S.A.California Books
Contact seller4-star sellerCondition: New
£ 154.50
Free ShippingShips within U.S.A.Quantity: Over 20 available
Condition: New. Print on Demand.
- Softcover
- Print on Demand
Seller: CitiRetail, Stevenage, United KingdomCitiRetail
Contact seller5-star sellerCondition: New
£ 145.99
£ 37.00 shippingShips from United Kingdom to U.S.A.Quantity: 1 available
Paperback. Condition: new. Paperback. BUILD A DEFENSIBLE DSCSA COMPLIANCE PROGRAM - FROM CHARTER TO INSPECTION READINESSFDA enforcement of the Drug Supply Chain Security Act (DSCSA) is now fully active across the pharmaceutical supply chain. Manufacturers, wholesale distributors, large dispensers, and 3PL organizations are all o…perating under live enforcement obligations - and FDA warning letters are already citing transactions with unauthorized trading partners, paper-based T3 data exchanges, and exception management programs with no documented root cause resolution. For compliance professionals, the challenge is no longer understanding what DSCSA requires. The challenge is having an operational SOP library, executed documentation, and a functioning exception management program ready for an inspector who can walk through the door without notice. A COMPLETE, OPERATIONAL COMPLIANCE PROGRAM FOR THE POST-ENFORCEMENT PHARMACEUTICAL SUPPLY CHAINThis manual delivers a fully executable DSCSA compliance program built for the current interoperability enforcement environment. Every chapter maps to a distinct compliance function - program governance, product identifier verification, EPCIS endpoint configuration, trading partner onboarding, authorized trading partner qualification, exception management, suspect product investigation, saleable returns verification, and FDA inspection readiness - and every chapter includes numbered SOPs with precise process steps, responsible party assignments, escalation triggers, input and output specifications, and completed sample forms. The program is built for wholesale distributors and includes documented adaptation guidance for manufacturers, repackagers, dispensers, and 3PLs. WHAT YOU WILL DISCOVER INSIDE THIS MANUAL30+ ready-to-implement SOPs covering the complete DSCSA compliance lifecycle with domain-coded numbering for instant cross-referencing.EPCIS endpoint configuration procedure with certificate management, authentication setup, and bilateral trading partner connectivity test protocols.Complete authorized trading partner verification matrices for all five trading partner types - manufacturer, wholesale distributor, repackager, dispenser, and 3PL.A six-category exception management KPI dashboard with corrective action triggers, root cause classification, and a completed monthly sample report.A scored FDA inspection readiness self-assessment tool with functional area guidance and interpretation thresholds. DEFEND YOUR PROGRAM WHEN AN FDA INSPECTOR ARRIVESAn FDA inspector reviewing DSCSA compliance will ask for the ATP qualification records for your last 12 months of transactions, the exception investigation log for a shipment flagged eight months ago, evidence that your EPCIS endpoint was tested before going live with every trading partner, and proof that a suspect product determination in your system triggered the correct notification pathway. This manual ensures every one of those documents exists, is correctly cross-referenced, and reflects current FDA enforcement expectations. Build a program that holds up under scrutiny - not one that only works when no one is watching. PROTECT YOUR PHARMACEUTICAL SUPPLY CHAIN OPERATIONS TODAYEquip your compliance team with the structured, enforcement-aligned tools they need to implement, audit, and defend a DSCSA program built for the post-enforcement supply chain. Add this essential compliance manual to your operations library today and move from reactive documentation to proactive inspection readiness. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
