Compliance & Validation Requirements for Serialization - Keys to Success
In this course, attendees will learn to identify critical areas of a packaging line that need to be validated for serialization. This will include new equipment, EPCIS, interfaces, and line serialization software. In addition to learning the impact of these actions on existing enterprise software applications and interfaces, the course will outline the required documents and processes for validating new packaging lines to support serialization. As an attendee, interactive learning principles and knowledge checks will help you develop a keen understanding of:
- How to identify key areas that must be validated
- What validation documents are needed, and who is responsible
- Critical stakeholders that must be involved in order to revalidate the line
This overview course will give attendees a foundational understanding of the validation process for a successfully serialized packaging line. This includes an emphasis on “how to validate” lines, and the most critical processes, stakeholders and equipment to consider.
This course will be of benefit to anyone involved in serialization, validation, quality assurance, or supply chain management on a global or domestic scale.
Roger Saumure has 25+ years of pharmaceutical and technology management experience focusing on Manufacturing, Demand Management, Strategic Planning, Supply Chain, and Customer Services as well as ERP and Revenue Management Systems selections and implementations. Roger served as the senior executive and board member of three European companies.
Most recently Mr. Saumure served as the VP at Edge Dynamics which was acquired by Imany. While at Johnson & Johnson and Rhone Poulenc Rorer (now Sanofi Aventis) He led major initiatives that included business process reengineering, design and ERP strategies. Mr. Saumure has extensive international experience in both Europe and Asia. He holds a Bachelors of Science in Chemical Engineering from Drexel University and Master in Business from University of Pennsylvania.