Saying the Quiet Things Out Loud

More Time, Same Problems: What the Industry Really Needs to Do To Achieve DSCSA Compliance

On Oct 9, 2024 the FDA announced further delays to the milestone of the DSCSA regulation. The new dates give manufacturers 6 additional months, wholesalers 9 additional months and non already-exempt dispenser an additional year. But will this additional delay really make a difference? Listen to hear our thoughts/opinions on what the FDA and Industry really need to be doing if we ever want to get to a point that DSCSA is fully and strictly enforced.

DSCSA Day and the DSCSA Portal

We discuss the signifcance (or insignificance) that was Nov 27, 2023. What do companies need to know going forward as well as a look back on the last 10 years We also dive into the new DSCSA Portal. What it's used for today, how that impacts company's SOPs and how it will bring the FDA (quickly) to a decision that has long hindered interoperability across the industry. I hope you enjoy! FDA DSCSA Portal: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-portal-cder-nextgen

doss digital

This week we talk about a service offering from Jennason called doss digital which helps companies leverage no code/low code technology to build business applications that solve business challenges quickly and cost effectively. ***If you take away nothing else from this episode- skip ahead to minute 13:18 to see a DSCSA relevant business application built in 2 minutes*** Learn More: https://doss.digital 00:00 Introduction 03:45 Introduction to QuickBase 05:21 Engaging with doss digital 13:18 Smart AI Builder Prompts 22:30 doss digital's No-cost/No-commitment offer

What One Email Can Tell You About Your Serialization Vendor

We are back with episode 5 of the Saying the Quiet Things Out Loud Podcast. Today we discuss how one single email can provide significant insight into your serialization vendor's position on key topics such as interoperability as well as their ability to support critical implementation and ongoing support operations including testing and data reconciliation. To make this as easy as possible we did the work for you. Below is a link to the email referenced in the episode. Copy/Paste and send it off to your vendor: https://www.lifescienceserialization.com/2023/10/the-email-every-company-should-send-to.html And when you hear back from your vendor- let me know your thoughts!! Other important resources mentioned in this week's episode NABP Pulse- https://nabp.pharmacy/pulse/ Initial NABP Pulse Partner Program Press Release (Say that 5 times fast)- https://nabp.pharmacy/news/news-releases/nabp-launches-pulse-interoperable-partner-program-to-accelerate-interoperability-in-drug-supply-chain/ Jennason Serialization Test Tool- https://jennason.com/solutions Solution Demo- https://youtu.be/JQdUON1fZBI FDA EDDS Guidance- https://www.fda.gov/media/171666/download

Build It And They Will Come

2 quick takes and the announcement of the Jennason DSCSA Trading Partner Directory * Introduction * Quick Take #1- DSCSA 'stabilization': Don't let vendors fool you into rushing * Quick Take #2: NABP Pulse and the curious case of who's missing https://nabp.pharmacy/news/news-releases/nabp-launches-pulse-interoperable-partner-program-to-accelerate-interoperability-in-drug-supply-chain/ [https://nabp.pharmacy/news/news-releases/nabp-launches-pulse-interoperable-partner-program-to-accelerate-interoperability-in-drug-supply-chain/] * Announcing the Jennason DSCSA Trading Partner Directory https://www.lifescienceserialization.com/2023/09/jennason-dscsa-trading-partner-directory.html [https://www.lifescienceserialization.com/2023/09/jennason-dscsa-trading-partner-directory.html]