July 24th @ 11AM EDT (8AM PDT)
Serialization Risk Mitigation and Contingency Planning – Are you ready for the US/EU Compliance Deadlines?
Join us for a webinar discussion on key milestones to evaluate and benchmark the health of your serialization program!
- -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?