DSCSA Updates: HDA Traceability, FDA Public Meeting, and More

By October 12, 2016 April 30th, 2018 Company News, DSCSA, Serialization, Track and Trace

There’s an intense feeling in the pharma industry right now – a mix of anxiety, excitement, and just plain old busyness in the face the DSCSA serialization deadline, which is just over a year away.

Manufacturers, distributors, and wholesalers are rushing to meet requirements while also trying to capture, understand, and incorporate all the news and information swirling around the business environment. We at LSPediA are no different: We have a lot to accomplish for our clients, a lot of learning to absorb, and some helpful news to share.

LSPediA to Present at the FDA Public Meeting, Friday, October 14

LSPediA is honored to announce that we will be giving a short presentation at the FDA’s public meeting taking place this Friday, October 14, in Silver Springs, Maryland. The FDA organized the event to provide pharmaceutical supply chain stakeholders a chance to share information about their experiences implementing product identification requirements and tracing at the product level.

Our presentation, “Scan-In, Scan-out, and Verify Serialized Drug Products for Supply Chain Data Integrity,” will describe our model for enabling serialized data collection at both receiving and shipping locations, and allowing for verification at return or on demand. If you can’t attend, we will be featuring highlights from the presentation in an upcoming blog post.

Join LSPediA at the 2016 HDA Traceability Seminar

riya-and-matt-at-hdma-dmc-2016While 2017’s serialization requirement is on the immediate horizon, an even bigger date lies just down the road beyond that: the DSCSA item-level traceability deadline of 2023. In response, the Healthcare Distribution Alliance (HAD) Traceability Seminar, taking place in Washington DC on November 9-11, is bringing together pharmaceutical supply chain colleagues, service providers, government regulators, and traceability experts for three days of conversation, networking, and presentations.

If you’re attending the Seminar, I hope you’ll come by our booth. We have three big reasons for you to do so:

  1. Demo RxChain, from LSPediA. Our latest DSCSA solution is an interoperable track-n-trace and serialization supply chain solution that is fully compliant with the requirements of DSCSA at its 2017 serialization phase, its 2019 wholesale distribution phase, and its 2023 interoperability phase. With this tool, manufacturers, 3PLs, wholesale distributors, and dispensers can:
    • Capture and verify serialization data with Scan-In and Scan-Out capabilities
    • Exchange data via EPCIS, XML, or file drops with track-and-trace functions
    • Guarantee product authenticity and inference with 2D verification
    • Use data analytics to drive better business decisions
  2. Discuss your serialization project. I’d love to schedule a brief meeting to understand your challenges, triumphs, and needs around DSCSA requirements. To request a meeting, please click this link http://meetme.so/LSPediA.
  3. Enter our $100 Amazon gift card We’ll be giving away a card each day of the HDA event, so come be our booth and enter to win!

Partner with LSPediA for DSCSA Compliance and a Competitive Edge

Complying with regulations and meeting standards around serialization and traceability is a complicated task. It’s also one of the most important tasks your business undertakes. Your reputation with partners and patients, and your bottom line, are all at stake.

If you need a guide to get you started and see you through to DSCSA compliance, contact LSPediA. We can ensure you understand and successfully implement GS1 standards, a DSCSA strategy, and serialization solutions. And along the way, your business will benefit from additional efficiencies around process improvement and better use of resources.

 

About LSPediA – Life Sciences Solutions

LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.

For more information about LSPediA, call +1 (248) 973-2008, email info@lspedia.com, or visit our website at www.lspedia.com.

For additional information, contact: Julianne Jahn jjahn@lspedia.com