FALLS CHURCH, Va. (PRWEB) June 11, 2018
Serialization is a still-new requirement for drugmakers in the U.S. And drug regulators globally from Brazil and Argentina to South Korea and Saudi Arabia are fast adopting new rules too.
Manufacturers selling drugs in global markets need to get up to speed on serialization and traceability requirements around the world.
FDAnews has reached out to an expert, consultant Bill Fletcher, to shed light in this complex new area of drug regulation. Mr. Fletcher helps clients cope with pharmaceutical serialization and tracking regulations around the world including the U.S. Federal Drug Quality and Security Act of 2013 (DQSA), China, the EU, Turkey, Argentina, India, South Korea, Saudi Arabia, Brazil and others.
Over 90 lightning minutes, attendees will discover emerging trends in serializing drug products and the systems that track and trace Rx drugs through the supply chain, emerging requirements that go beyond the terms of the Drug Supply Chain Security Act (DSCSA), specific developments in Brazil and China, two of the fastest-growing emerging markets, new international laws and much more. This webinar will equip drugmakers to:
- Comply with new global traceability requirements
- Manage child-to-parent aggregation, a particularly frustrating aspect of serialization
- Skirt pitfalls in track-and-trace, based on experience with some 30 implementations of traceability
- Move beyond simple DSCA compliance to underlying complexities
- Deploy state-of-the-art traceability based on cutting-edge third party logistics
- Implement EPCIS (Electronic Product Code Information Services) and other key standards
Failure to achieve mandated milestones could result in manufacturing suspensions until needed systems are implemented. And given the number of countries imposing regulation, those milestones could easily sneak past manufacturers.
Meet the Presenter:
William (Bill) Fletcher, Managing Partner, Pharma Logic Solutions LLC. With a background spanning 34+ years in pharmaceutical, enterprise software and healthcare systems, Mr. Fletcher’s consultancy focuses on helping clients cope with pharmaceutical serialization and tracking regulations around the world – the U.S. Federal Drug Quality and Security Act of 2013 (DQSA), China, EU, Turkey, Argentina, India, South Korea, Saudi Arabia, Brazil and others. Services for clients also include e-Pedigree strategy, project roadmaps, user and functional requirements, vendor selection, pilot planning and tests, validation, risk or REMS assessment and project planning.
Who Will Benefit:
Drugmakers, contracted packaging organizations (CPO), contract manufacturing organizations (CMO), third party logistics (3PL) and drug wholesalers/distributors all will benefit from this presentation. Specific job titles include executives in:
- Regulatory affairs
- Warehouse management
- Shipping management
- Trade operations
- Enterprise resource planning (ERP)
Real-World Serialization in Life Sciences — 2018
Track & Trace at a Global Crossroads
**An FDAnews Webinar**
June 20, 2018 — 1:30 p.m. – 3:00 p.m. ET
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.