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 most importantly, correctly.

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 important question to ask your serialization vendors, like how customizable is the platform, and who is in control of upgrades – me or the solution provider?
• 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.

Speakers

Tim Donelon, Director of Quality and Validation, Verify Brand

Tim Donelon has more than 17 years of experience leveraging his people management and technical skills to improve organizational performance in the pharmaceutical, biopharmaceutical, and medical device industries. He has held numerous management and technical roles in US-based pharmaceutical and medical device companies, where he led high-performance teams in the following areas: conducting regulated and non-regulated computer systems implementation and validations; implementing application and staff integrations for company acquisitions and divestitures; maintaining, managing and validating computerized systems; creating policies and procedures; implementing electronic records and signatures; designing quality management systems; leading audits. Tim’s certifications include Six Sigma and Certified Quality Auditor (American Society for Quality), and he is a member of the International Society for Pharmaceutical Engineering (ISPE).

Message Presenter

Scott Pugh, Solution Architect, Jennason

Scott’s deep and broad serialization knowledge is a result of more than 10 years of Fortune 500 consulting and solution provider experience. His work has supported global organizations across multiple industries including pharmaceuticals, medical device, electronics, consumer goods and food/beverage. Since 2007, Scott has focused exclusively on serialization and traceability solutions. Whether he has provided advice and innovative technology solutions for regulatory compliance, supply chain security or process efficiency, Scott has helped organizations leverage serialization and traceability to reduce effort and cost, gain a strategic advantage, and maximize business value.

Message Presenter

Haris Kamal, Senior Vice President, Verify Brand

Haris has 20 years of experience helping life science, CPG, retail and entertainment brands create a path to success through technology. His focus is on the intricacies of U.S. and global pharma regulations, and delivering the right serialization compliance solution. With a background in ERP and supply chain, Haris has more than a decade of experience providing leadership at serialization and traceability providers rfcxcel and Frequentz, and currently holds a senior leadership position at Verify Brand.

Message Presenter