Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include:Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations→
RxTrace is proud to sponsor the 2014 UDI Implementation Workshop to be held in Baltimore on May 20-22. The UDI Implementation Workshop is specifically for Class III medical device manufacturers who are in immediate need of information and guidance from the UDI experts at the FDA to meet their September 24, 2014 compliance deadline, and for those Class I and II Device manufacturers that need to jumpstart their UDI adoption efforts.
The FDA UDI Team will conduct a roll-up-your sleeves / deep-dive workshop covering all components of the UDI regulation and the Global UDI Database (GUDID) guidance. This workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative. If you need to meet the September deadline, don’t miss this workshop. It is perfectly timed to give you the boost you need to be ready on time. Continue reading Bringing UDI and the Global UDI Database to Life→
I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time. The material they cover is a good overview of the new law at a high level. The tough part for the speaker comes at the end when the floor is opened up for Q&A. There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance. Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.