rapid compliance webinar slides
TRANSCRIPT
WEBINAR
15 February, 2017
SERIALIZATION SIMPLIFIED
This webinar is intended to be
interactive
Information contained in this webinar is current as of
February 2017
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BEFORE WE DIVE IN…
WEBINAR SERIES
Stephen LisaDIRECTOR, PRODUCT MANAGEMENTFOR SYSTECH INTERNATIONAL
Stephen’s 20 years of experience at Systech include product management, software development, customer deployment and customer support. Mr. Lisa has performed extensive product definition and development activities and worked with customers on serialization packaging deployments and the original serialization pilots. Other roles performed during his years include conducting analysis design and architecture meetings with customers, defining requirements for packaging, serialization and enterprise applications, specifications for hardware platforms, management of the engineering team, and collaboration on Systech’s product roadmap.
PRESENTER
SERIALIZATION DEADLINES ARE
FAST APPROACHING
DEADLINES ARE CLOSING IN
5
DSCSA – November 2017
POLL
WHAT BUSINESS CHALLENGES ARE WE TRYING TO SOLVE?
Comply with global regulations Confirm market access Avoid quarantineLine readiness Limit downtime Ensure proper product handlingException handling In-lot Post-lotSupply chain readiness Data access and data exchange Trade partners
DATA REALITIES ARE NOT THE
SAME BY GEO
DATA REQUIREMENTS DIFFER PER MARKET
Know the data regulations that pertain to each market. Different markets pose different requirements.
• Some markets require product master data to be reported separately.• Some markets require multiple reporting requirements.• Some markets require barcodes with different data combinations encoded in them in
addition to specific human-readable data.• Some markets indicate the manufacturer is solely responsible.• Some markets require inclusion of a National Reimbursement Number or application
of labels for similar purposes.• Some markets have influential stakeholders which are impacting guidelines.• Some markets define events differently (ie: decommissioning)
CODING VS REPORTING
Serialization Coding GS1 widely adopted (01)(21)(17)(10)…. Barcoding quality spec standards Data carriers widely adopted (2D, 1D, QR) Printers and inspection equipment at generation 3, 4, 5 and beyond
Compliance Reporting Reporting output requirements are vague….. Hub model vs chain of custody model The influence of wholesalers What to report and when?
ENSURE YOU HAVE THE DATA READY NOW FOR WHATEVER IS COMING!!!!
?
WHERE DO I EVEN START?
? ? ?
Food for Thought What resources do I need? Which markets do I deliver product to? What lines at what sites run which products? What is the best deployment model? Do I have the data model to support compliance? What is the timeline? How much does line downtime cost? What happens if……?
POLL
FAST COMPLIANCE IS NOW
NECESSARY
DEFINE ALIGN DIVIDE DEPLOY
WHAT ARE THE BEST PRACTICES FOR PROJECTS?
RAPID COMPLIANCE CHECKLIST
What markets am I selling to?
What sites and lines are in Phase 1?
What are my “as-is” line workflows?
What are my current print/labeling formats?
Are all the stakeholders for serialization involved?
Are we controlling project scope / scope creep?
Where am I required to send my serialized data?
DEFINE ALIGN DIVIDE DEPLOY
RAPID COMPLIANCE BEST PRACTICES
Phase 1 Scope Stakeholders Parallel Tasks Start Up
One Partner responsible for• Site Serialization Infrastructure• Standard Catalog Offerings• Total Project Management• Delivering Configured Line Solutions• Expert On-Site Services • Post Implementation Support
Rapid Deployment• Pre-engineered packaging stations• Pre-defined workflows• Regional installation services network
SERIALIZATION SIMPLIFIED PREPACKAGED SOLUTIONS
Experienced manufacturers working together to bring serialization ready packaging machines to the market
Machines are serialization ready with all interfaces and workflows defined and tested
SUMMARY
ACHIEVE COMPLIANCENumerous evolving regional regulations
KNOW YOUR DEPLOYMENTRapid deployments can only occur when the parts are aligned
SYSTEMS UNITE Multiple vendors and interfaces
DATA IS KINGGather data and provide value
BE READY FOR ANYTHINGHappy path vs unhappy path
KNOW AND MEET MARKET REGULATIONS
IDENTIFY THE TEAMS,KNOW THE MODEL, EXECUTE
STANDARDIZE YOUR SOLUTIONS
ENSURE YOUR BRAND IS PROTECTED
EXCEPTION HANDLING, BE AWARE
READY. SET. GET SERIALIZED BY NOVEMBER 2017.
The Systech “Serialized by November” Rapid Compliance Program provides the shortest path for companies to be DSCSA
compliant in 90 days.
Systech is currently onboarding customers from now until August 1
under this program.
Our Program includes: • Multi-level serialization• Site and line management configuration• A built-in foundation for future lines, documentation• Factory Acceptance Testing (FAT)• Ready for Site Acceptance Testing (SAT)
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