Mind the Gap! Labeling Experts share the 7 Steps of building a Global Labeling System and reducing the Validation effort
Sponsored by: PRISYM ID
Date: 26 January
Time: 4PM London/11AM New York
Labeling Webinar Series - A Date with the Experts on Global Labeling Systems
For many life sciences organizations, bridging the gap between an existing labeling system and implementing a global labeling solution as part of the supply chain can be a key concern. Businesses must find ways to overcome the challenges of global implementation, validation, label inspection, language management and label postponement, whilst managing time and costs.
Join us for the first of our 60 minute webinar series, featuring leading industry experts who will discuss how you can bridge the gap by learning the 7 steps of implementing label lifecycle management solutions and will demonstrate how to seamlessly manage your validation effort.
Implementing a Global Labeling System - Chris Heckert - Network Packaging Partners
This session will talk about the steps, cadence and requirements on moving from an existing labeling system to a Global Labeling System. The seven basic steps to implementing a labeling system will be presented, as well as examples to consider when planning the implementation of your Global Labeling System.
Reducing Validation Effort by Leveraging your Supplier - Phil Dray - PRISYM ID
The effort and time-period to perform computer systems software validation should not be underestimated. Along with resource constraints and the constant challenges to deliver validation quickly and efficiently, a least burdensome approach must be employed.
This session will explore an approach to reducing validation effort by leveraging the supplier resources (test documents or SME's) available to you. This will include first principles through supplier Audit to the type of documentation that should be leveraged to reduce your validation effort.
Director Client Solutions, Network Packaging Partners
Chris is a degreed Packaging Engineer from Michigan State University with over 20 years’ experience in the medical device industry. Most recently, he was responsible for choosing and implementing a Part 11 compliant Global Labeling System for Orthopedic giant Zimmer at eight separate design control sites including a European Distribution site.
When the job was completed, all sites shared a validated, compliant labeling system and due to the ability to print single language IFU's (Instructions For Use) at the point of distribution, Zimmer saved over $6MM/yr and reduced its waste stream of paper by over 175 tons/year.
Senior Test and Validation Engineer, PRISYM ID
Phil is Senior Test and Validation Engineer at PRISYM ID, assisting our clients in meeting regulatory compliance to FDA, MHRA, EU and GMP for the company software products supplied to the life sciences industry. He also ensures that validation documents and processes are in line with current regulatory guidance, and delivers onsite training for PRISYM ID’s proprietary software. He provides test plans and processes to ensure software products are robust before release.
Phil started within the electronics industry and moved into computing through field/customer service. He has been with PRISYM ID for 24 years and has contributed through customer service, installation and customer training. He has extensive experience in software test and process planning.
Key Learning Objectives
- Gain an understanding of global labeling lifecycle in practical terms
- Hear advice from experts on the 7 steps of how to implement and validate your labeling project
- Realize how to achieve zero-defect labeling and full traceability
- Build efficiency into your label production process
- Manager/Head /Director/VP of Labeling and Packaging
- Manager/Head /Director/VP of Manufacturing
- Manager/Head /Director/VP of Regulations
- Manager/Head / Director/VP of Quality
- Manager/Head / Director/VP of Compliance
- Manager/Head/ Director/VP of Logistics
- IS/IT Managers/Heads/Directors/VP