Saleable Returns has been the hottest topic in serialization the past couple of months, but depending on who you ask, you get different answers on what it means and how it impacts your company.
Our white paper last month solicited so many great questions that we thought it was worthwhile to ask the true experts who are in the middle of preparing themselves and collaborating with every segment of the supply chain and industry work groups.
- Even though it’s a wholesaler requirement, what are the financial and supply chain risks to a manufacturer not passing data and of not utilizing a VRS?
- Will the VRS vendors be ready and truly interoperable?
- Is VRS a short-term fix or a potential long-term solution?
- What is a the risk for a wholesaler and manufacturer solely relying on EPCIS or VRS and not preparing for both?
Meet your presenters and moderator:
- Jeff Denton: Sr. Director, Global Secure Supply Chain (AmerisourceBergen)
- Matt Sample: VP, Manufacturer Operations (AmerisourceBergen)
- Greg Cathcart: CEO (Excellis Health Solutions)
Avoid the “building the plane while flying it” feeling.
Is your company infrastructure (Quality, IT, Supply Chain) ready to support a Commercial Launch? What needs to be done, when, in what order, and on what scale?
SVA Bio-Ops will be speaking on…
- Demystifying Commercialization
- Mission Critical Timelines
- Managing Risk and Making Safe Bets
Excellis will be speaking on…
- Regulatory Readiness
- Quality Processes/Systems
- Serialization Compliance
- Bryan Bechtoldt, MD, EdD – President & Principal, SVA Consulting
- Scott Potteiger – Vice President, Excellis
Hear from a panel of experts from Takeda, Excellis Health, and RXTrace on…
- -The biggest risks of stopping at compliance
- -How to leverage your serialization investment
- -Simple steps to achieve absolute brand protection with minimal effort
- -Are you in a fully validated Production environment?
- -Are your CMOs and 3PLs on-boarded and live?
- -Will you need to up-version your solution to be in compliance?
- -What is your backup plan–is it too late to switch vendors?
- -Are your SOPs defined and updated to account for serialized operations?
- -Has your equipment delivery been delayed?
- -Are all your lines installed and qualified?
- -Are you aggregating now or do you have plans for the future?
- -Is building safety stock a viable risk mitigation strategy?
- -How/When do you switch CMOs who aren’t ready or responsive?
- DSCSA regulation update, timelines and operational implications
- Office of Inspector General (OIG) March 2018 Report
- Federal Drug Administration 2 new guidances
Purchasing or replacing a Track and Trace DSCSA Technology Solution? Learn the 5 key elements to ensure a great selection in meeting your organization’s needs. Learn About…
- DSCSA regulation update & timelines for consideration in selecting a technology solution
- Compliance and operational value – can both be achieved with a technology solution?
- Key elements in comparing and selecting a technology solution
- Considerations of pharmacy manufacturers serializing product by 11/2018
- Advantages for the pharmacy supply chain
- Why are so many organizations considering changing solution vendors?
- Key Elements to ensure compliance and improve medication & patient safety
- Implications and Opportunities of the November 2017 electronic lot traceability date
- FDA’s 11/27/2017 guidance regarding grandfathering product & implications for healthcare and retail
OIG and FDA latest report/guidance & Are you prepared for Electronic Lot Traceability November 2017 Deadline Impact
- What are the implications of Wholesalers exchanging drug product tracing information using a wide variety of transmission modes and formats?
- Are direct purchase statements accurate with the required information?
- How is the determination of DSCSA exempt and non-exempt products? How trading partners might resolve/prevent disagreements?
- 340B pharmacies: What is the latest guidance regarding the exchange of drug product tracing information for sales to 340B-covered entities that use 340B contract pharmacies?