The DSCSA requires wholesale distributors (WD) and third-party logistics providers (3PL) to report licensure and other information to the FDA annually. This reporting is through FDA’s CDER Direct Electronic Submissions…
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At last week’s HDMA Traceability Seminar in Washington DC, Serialization Master Data Management was the talk of the day. When companies go down the path of implementing serialization, they quickly…
Good news: you can now register for a free membership to LSPediA.com for a limited time! Members are able to access exclusive multimedia content including an archive of highly informative…
The Drug Supply Chain Security Act (DSCSA) was passed into law in the US on November 27, 2013 with increasingly more difficult requirements over time. DSCSA impacted key members of…
The webinar was aired on 3/17/2015. Please click Recording to watch this webinar. Webinar description: With the DSCSA January 2015 deadline behind us, let’s take a look at what the FDA and…
“Beginning not later than January 1, 2015…a wholesale distributor shall not accept ownership of a product unless the previous owner…provides the transaction history, transaction information, and a transaction statement…” –DQSA, Title…
On November 18, 2013, the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204), setting forth a series of new compliance requirements for the pharmaceutical manufacturers, distributors, and…
On September 24, 2013, FDA published the Unique Device Identification System final rule requiring device manufacturers distributing to the United States to carry UDI compliant labels and submit UDI data to the…
Serialization is a companywide initiative that spans multiple business units including engineering, operations, RA, QA, QC, supply chain, services, and IT. The sheer complexity of the project can be overwhelming…
The serialization and ePedigree project has many touch points with various operations. Approaching the project without a proper plan and the skillful project management bears the risk of scope creep, budget…
Effective January 1, 2015, manufacturers, wholesalers, and distributors are required by the California Pharmacy Pedigree Law to ship serialized products and track the product movement using ePedigree communications. Wholesalers and…