Last week, I wrote about commissioned serial numbers and questioned whether getting only commission serial numbers from the CMO is sufficient. Before I can answer that question, let us first take…
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Upcoming Webinar Global Serialization 3 of 3: A Closer Look at EU Falsified Medicines Directive (Thu, Dec 3, 2015, 11 am Eastern Time) EU Falsified Medicines Directive (FMD) became effective…
When it comes to event data for serialized products, many individuals are confused about both the events and the data. Take commissioned serial numbers for example: commissioning is the event,…
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…
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…