Ten Count Consulting

In our latest blog, we expand on our recap of the recent HDA Traceablity Seminar. Did we miss any key points? #dscsa https://lnkd.in/gFAqXC-7

The countdown continues.. Just 58 business days until November 27th! Reach us at info@tencountconsulting.com #dscsca https://lnkd.in/gc8FiAA7

Another HDA Traceability conference in the rearview mirror! We will try to recap more in a blog but here are some key themes we picked up: 1- Stay in regular communication with trading partners, contractors, regulators, and others. 2- No slowing down, move to exception handling prep and mock audits if you feel solid on core requirements. 3- All trading partners need to take a serious but quick look at their readiness for November. 4- Data exceptions at the point of dispense could lead to serious problems for pharmacies. Work to avoid now. 5- While submitting a WEE Request might raise risk of "being a target", realize not submitting a WEER for your product may be worse if your partners have to include you on a WEER to mitigate or it risks product movement later. See point 1 above. 6- Make sure you have clear ownership for all aspects of DSCSA as you move away from project teams to operations. 7- Get any GTINs you package in the VRS lookup directory and monitor downstream experience. 8. Make sure anyone in your organization who can get any type of inquiry has procedures and knows what to do. (Regulators, product trace, verification, suspect product, etc). 9- NDC 10 to 12 digit coversion coming next is going to be the rising next big challenge by next year. Look for FDA finalization end of 2024 or 2025. 10- Reach out if you want to know more or how we can help you make it down the home stretch. info@tencountconsulting.com

Welcome to 2024 HDA Traceability! Stop by our table for some DSCSA discussions and a road warrior gift! #dscsa

How does DSCSA Impact 340B Drug Pricing Product? We share insights and highlight questions in our latest blog. #DSCSA https://lnkd.in/giyeq3Zt

Don't miss the largest DSCSA related event of the year. Stop by our table top #1! More info and register at https://lnkd.in/e79wEpXP #dscsa

Kudos to PDG for a useful and rare look at DSCSA readiness across all pharma sectors including a variety of dispensers with a bit heavier engagement from hospitals. Further evidence of progress but also a harsh reality of limited time to close the remaining gaps highlighted. We are always ready to discuss how your organization is be progressing. #dscsa

Why do you need an independent DSCSA asessment or mock audit? Feedback from satisfied clients: - We didn't realize the importance of fresh eyes with industry insights. - It helps to see now, areas we missed with project teams. - We now have clear evidence for budget and if we need an exemption request. - It shows leadership and auditors how we really care about patient safety compliance. Schedule your free consultation session today! https://lnkd.in/gPXC86vh

Don't miss this chance to hear from some leading voices helping the industry move towards DSCSA! Register through the link:

Did you miss the August 1st recommended submission date for DSCSA exemption? FDA has been clear there are no intentions for further broad delays beyond November, we can help you determine if you need to act now. #dscsa https://lnkd.in/gafeEEGw