24 Feb Assess Your Compliance Readiness: Tips for DSCSA Implementation – Faster, Easier and Done Right
With the November 2017 DSCSA regulatory timelines only a few months away, pharmaceutical manufacturers, CMOs, wholesalers and repackagers must objectively assess their compliance readiness now. DSCSA compliance and serialized workflows involve a lot of complicated moving parts, so while time is of the essence, your organization needs to quickly and carefully evaluate the systems, partners and technologies that will help you achieve compliance – faster, easier and done correctly.
Verify Brand is partnering with Xtalks to bring you a free 60-minute webinar on March 15 from 1 pm to 2 pm EDT called, “Assess Your Compliance Readiness: Tips for DSCSA Implementation – Faster, Easier and Done Right.” Wherever you are in your DSCSA preparedness, this webinar will provide practical tips that will help you meet regulatory timelines today and ensure successful serialization in the long term.
This webinar’s panel of pharma serialization subject matter experts will cover:
Data, the network and standards – You’ll learn why it’s important to understand the content of the data that will be exchanged with trading partners (e.g., tracking-event data, type of identifiers, required master data), as well as the mechanisms that will be used to transmit or receive data. We’ll review what the basic four dimensions for critical data tracking events are; how connections are made between trading partners; and why standard messaging formats, specifically GS1’s EPCIS 1.2, are critical for faster, easier data exchange. Finally – and perhaps most importantly – we’ll give you tips to tell whether a serialization vendor really has the necessary universal connectivity for seamless, painless partner integrations.
Validations – Validation is an important step that includes installation, testing, protocol execution, and documentation approvals. When done well, validation can help the implementation process to go smoothly. Conversely, it can cause major disruptions to your business if your solution provider’s process is flawed. We’ll share key questions to ask your serialization vendors, like what is the re-verification process if there are software updates?
Support – A key element to the success of your serialization project is having the right support team in place. You should not only consider whether a vendor’s solution meets all of your data and technical requirements, but also whether the vendor itself is a good business fit. Does the vendor have the capacity to support your company adequately? What project management experience does the vendor have supporting serialization for companies comparable in size, geography and type of business? What will be the total cost of ownership for the serialization solution – is ongoing support a hidden cost? Finally, if you feel you’ve selected the wrong vendor and need to switch to a different vendor, is that possible and what will the process be for transferring data and cutting over operations?
While DSCSA deadlines are top of mind for everyone in the pharma industry, it’s important to recognize the strategic importance of serialization – knowing exactly where a product is through all steps of its lifetime. This webinar will provide tips not only for quick, pain-free implementation as you’re assessing your DSCSA compliance readiness today, but will also help you lay a solid foundation for your serialized workflow that will provide benefits for many years to come.