Is Your Serialization Program Complete and Sustainable?

The FDA’s Drug Supply Chain Security Act (DSCSA) deadline requiring all pharmaceutical manufacturers and suppliers to serialize individual units and provide electronic track and trace for every product that travels through the supply chain was November 27, 2023. Join this discussion led by Bill Fletcher, Senior Director of Traceability and Electronic Client Communications at Knipper Health, to help you consider the critical topics for compliance and potential options for resolution.

Register Free: https://www.pharmaceuticalcommerce.com/pc/serialization-program

Event Overview:

The FDA’s Drug Supply Chain Security Act (DSCSA) deadline requiring all pharmaceutical manufacturers and suppliers to serialize individual units and provide electronic track and trace for every product that travels through the supply chain was November 27, 2023. Full implementation of these requirements can be complicated, costly, time consuming and confusing. This discussion led by Bill Fletcher, Senior Director of Traceability and Electronic Client Communications at Knipper Health, will help you consider the following topics including various options for resolution.

• Is your project complete?
• Have you considered all the exceptions?
• Have you considered back-up or alternate options to continue to ship your product? Are you confident your buyers are ready to accept the information?
• Do you have what is required to meet the requirements or are you still struggling with implementation and compliance?

Key Learning Objectives:

• Understanding serialization exceptions and how to handle them
• Understanding what is required to provide a sustainable serialization solution.
• Options for achieving these goals quickly
• Lessons learned from over 65 serialization implementations with many of the largest life science companies in the world.

Who Should Attend:

• Those responsible for serialization implementation.
• C-suite executives who wants to understand the risks.
• Supply chain VP, Directors
• Logistics VP, Directors
• Procurement VP, Directions

Speaker:

Bill Fletcher
Senior Director, Traceability and Electronic Client Communications
Knipper 3PL

Bill Fletcher is an experienced executive with a 41-plus year history in the life sciences industry, with leadership roles in pharmaceutical and biotech packaging and labeling, research and development, warehousing, distribution, and medical devices.

For 18 years before joining Knipper Health, Fletcher was managing director of Pharma Logic Solutions, LLC, a consulting company that specializes in compliance with global traceability and serialization regulations. He has assisted over 65 manufacturers, wholesalers and 3PL and distribution providers to implement serialization systems, packaging, labeling and related procedures—including several of the world’s largest drug or distribution providers—with both internal or contracted manufacturing, packaging and distribution.

For decades, Fletcher has spoken to audiences of hundreds during industry events around the world and across the United States. In 2013, he was asked to share his experience by speaking in the U.S. Capitol to congressional staff developing the Federal Drug Quality and Security Act (DQSA) of 2013, and more specifically, its Title II, the Drug Supply Chain Security Act (DSCSA), to improve the integrity of the U.S. drug supply chain and foster greater patient safety.

Register Free:
https://www.pharmaceuticalcommerce.com/pc/serialization-program