ISPE SAN DIEGO CHAPTER
Operation Management Event
Date: Thursday, May 17, 2012
Time: 7:30 am to 4:00 pm --- Xyntek's Presentation at 11:00am
Location: Genentech- 1 Antibody Way, Oceanside, CA 92056
Synopsis of Xyntek's Presentation:
Supply Chain Management as it relates to E-Pedigree Implementation
Speaker: William Fletcher, Project Director, Xyntek , Inc.
This presentation provides strategy for three different yet intertwined areas -- regulatory compliance, counterfeiting, and brand protection. While speculation continues over federal legislation to preempt the current State of California drug traceability law requiring electronic chain-of-custody (e-Pedigree) documents for each item shipped, many companies are refining their strategies and requirements to deploy unit serialization now. These same companies are prototyping the various likely federal requirements and e-Pedigree should federal legislation fail to preempt the California mandate. Likewise, Brand Protection and Security teams are now common within pharmaceutical, wholesaler and pharmacies companies due to the overwhelming benefits of protecting the resources and investments made into the delivery of a given product. Global counterfeiting is estimated to be a multibillion dollar problem and manufacturers have to protect against this major health concern and lost market.
Learn how to:
* Plan for, any type of serialization, pedigree or bar coding efforts for products within the supply chain
* Protect your brand/brands image through traceability
* Combat counterfeiting, diversion and fraud
* Ensure marketing/supply chain/regulatory silos within your organization work together to protect brand identity
* Coordinate, with the other pieces of the supply chain (manufacturers, wholesalers, pharmacies) on traceability efforts
William (Bill) Fletcher's background spans over 29 years in the pharmaceutical industry. His experience in life sciences includes supply chain intelligence, serialization, packaging/labeling execution systems (PES) and machine vision inspection systems, barcoding, radio frequency identification (RFID), distribution systems, chain-of-custody e-Pedigree/RxASN, supply chain track and trace and improving overall equipment effectiveness (OEE). His experience also includes healthcare information systems (HL7), medical devices, drug discovery and R&D, clinical trials, and pharmaceutical physician education.
Mr. Fletcher is currently focused on pharmaceutical serialization, track and trace and anti-counterfeiting. He has developed serialization and e-Pedigree strategy, requirements, vendor selection and project planning for multiple companies. To date, Mr Fletcher has completed 12 projects to deliver strategy, define requirements, select vendors and perform prototyping and pilots with leading life sciences manufactures relating to tracking/tracing, electronic pedigree and supply chain visibility and security.
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