FDAnews Announces — Serializing Your Global Supply Chain: Myths and Misconceptions about Track and Trace Webinar, Dec. 15, 2015
Falls Church, VA (PRWEB) November 25, 2015 -- Serializing Your Global Supply Chain:
Myths and Misconceptions about Track and Trace
Dec. 15, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/serializingyourglobalsupplychain
Join FDAnews and track and trace expert Evren Ozkaya, Ph.D. on Dec. 15, 2015 to tackle the numerous issues and misconceptions surrounding new track and trace requirements.
The requirements for track-and-trace are relatively new, and new aspects of them are continually coming into force. As of May 1, 2015, the Drug Supply Chain Security Act (DSCSA) is fully enforced for manufacturers, wholesalers and repackagers, with many additional requirements (such as for pharmacies) going into effect at a later date.
Currently, manufacturers must incorporate product transaction data into a single document that is available, either electronically or on paper, each time ownership is transferred. This must include transaction data listing, lot-level information, a complete transaction history and a transaction statement, and must be maintained for six years afterwards.
By November 2017, that information must be available electronically, and the product identifier must be affixed or imprinted on the label at the product and case level. This lot-level serialization will present a major challenge for drug manufacturers, requiring extensive work at every point of their supply chain.
This extends to the global level: serialization requirements are in various stages of development in the EU and in its member nations, as well as in Turkey, India, China, Brazil, Argentina and Korea. The most recent change occurred in Brazil, where all pharmaceuticals must be serialized and tracked by Dec. 10, 2016.
If manufacturers are concerned about the new requirements they shouldn’t miss out on this opportunity to get detailed input from this acknowledged expert. In just 90 minutes, attendees will learn:
• Deadlines for serialization and how the timeline must reflect them
• Old technology vs. new: How the supply chain needs to transform for compliance
• The biggest myths and misconceptions about track-and-trace
• Thinking globally: Is the U.S. lagging behind the rest of the world?
Meet the Presenter:
Evren Ozkaya, Ph.D.
Founder and CEO at Supply Chain Wizard, LLC
Mr. Ozkaya is an operations & strategy executive and entrepreneur with 11 years of deep experience in research, design and implementation of supply chain strategies and transformation initiatives across seven industries, primarily focusing on the pharmaceutical industry, with a track record of high impact projects, while building and coaching talented teams for sustainable results.
Who Will Benefit:
• Auditors
• Compliance officers
• Consultants/service providers
• Data management and statistics personnel
• Executive management
• General/corporate counsel
• Investigators
• Managers
• Manufacturing directors and supervisors
• Pharmaceutical and cGMP auditors
• QA/QC personnel
• Regulatory/legislative affairs professionals
• Risk management specialists
• Strategic planning and business development staff
Webinar Details:
Serializing Your Global Supply Chain:
Myths and Misconceptions about Track and Trace
Dec. 15, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/serializingyourglobalsupplychain
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/serializingyourglobalsupplychain
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
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.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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