Although the 2017 DSCSA deadline will be past us, the challenges surrounding global serialization are still top priority. Now with FDA enforcement discretion giving another year cushion, there is more time to work out the kinks. Operationalizing serialization is an ongoing process that needs continual adjustments to account for bottlenecks, validation challenges, data inconsistencies, onboarding new supply chain partners, and more. How can we ultimately reach the 2023 deadline of a fully interoperable system if we cannot work out all the kinks occuring now? Looking past the US, the looming EU deadline is a top priority that must be considered in your 2018 plans.
Learning from each other is the key to success. We must have the hard conversations around inaccurate data transfers, packaging & labeling mistakes, aggregation, and saleable returns, to name a few. And then we can take things up a notch…..What will 2023 and beyond ultimately look like? How will new technology like cloud & block chain affect us?
OPTEL will be fully recapping the FDA workshop in an intimate, interactive setting with top serialization experts who were there, including OPTEL’s Chief Technology Officer, Jean-Pierre Allard. Whether you are attending the FDA workshop or were not able to reserve a seat, this event is the premiere venue to deliberate on all that occurred, key regulatory updates, and what is expected next.
Senior Director Chris Collins will also be leading an Interactive Discussion Group on what to do when your partner requires a software upgrade whilst ensuring your lines won’t go down!