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About David DeJean
David DeJean, Vice President, is responsible for Systech’s Center of Excellence, which supports and educates customers and stakeholders on best practices for implementing Enterprise Serialization, Track & Trace and Authentication solutions. DeJean brings a wealth of market knowledge, hands-on experience in serialization solution development and project methodology. His role includes staying abreast of international regulations, business and industry drivers, and supporting customers and stakeholders, defining high performance, cost-effective solutions that are integrated and expandable to meet future needs. DeJean is a serialization subject matter expert, previously holding various roles within Systech including, Engineering Management, Product Marketing, Professional Services and Sales Management.
Systech International is the global leader in brand protection technologies, with solutions that address the needs of Enterprise Serialization, Authentication, and Track and Trace, serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
As global supply chains become more complicated and counterfeiting threats continue to grow, Systech will continue to be at the forefront of brand protection innovation.
On November 2013, President Obama signed into law The Drug Quality and Security Act (HR 3204) that authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, stolen, and harmful drugs. The law replaces State level ePedigree regulations.
The bill clarifies Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers - large compounding entities called ‘outsourcing facilities.’
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
The electronic tracking system is designed to prevent counterfeited or stolen compounded prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to add electronic codes to track medicines from factories to pharmacies. Pharmaceutical serialization, transaction verification, lot and unit-level tracing, and other requirements come into effect as early as Jan 1, 2015.
New and existing companies face some regulatory confusion and legal risks. Hence, enforcing the new act may be delayed. This gives companies the opportunity to prepare early for the impending regulations by attending this webinar.
This webinar will address some important issues regarding the new law:
• H.R. 3204 Regulatory Overview
• The Manufacturer and H.R 3204
• Wholesale Distributor and H.R 3204
• Dispenser Focus and H.R 3204
• Re-packager / 3PL and H.R 3204
• Regulatory and business implementation issues
• Key definitions for product and transaction requirements
• Serialization requirements for packages
• Product tracing (lot and unit level) of transaction history, statements, and information
• Requests for information on transaction histories
• Verification of product identity and transaction requirements
• Data retention, returns, drop shipments, grandfathering
• Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress was established with the mission to produce unbiased, objective, and educational live webinars that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format. To contact or register to an event, please visit: www.knowledgecongress.org.