Medical Device Labels: Using Integrated Vision to Achieve 100% FDA Compliance

Life Sciences, Medical Device, Medical Device Safety and Regulation, Pharmaceutical, Pharmaceutical Regulation ,
  • April 06, 2016

Labeling is an integral component within the medical device production process, with manufacturers needing to ensure products are correctly identified and branded in accordance with the FDA’s stringent regulations.

Currently, ensuring label integrity frequently involves a two-stage process, with the design and print process often being managed separately from the inspection process, either on an ad-hoc basis and / or off-site from the label print production.

This approach can be prone to human error and cause unnecessary delays in the manufacturing process, as errors need to be identified and corrected manually. More importantly, it puts medical device manufacturers at risk of non-compliance with the FDA 21CFR820.120 and 21CFR820.30 regulations.

By integrating the label design system with the print inspection hardware you can achieve a single process to overcome these risks and costs associated with manual processes inspection.

Key Takeaway Points

  • Achieve an understanding into best practice for managing defect control.
  • Learn why print verification systems are becoming an essential part of the production line.
  • Understand how an integrated solution can reduce cost, increase operational efficiency and guarantee label accuracy.

Join us for a 45-minute presentation plus Q&A session to understand better the industry’s current inspection challenges and for a demo of a pioneering fully integrated label management software solution with a print inspection hardware.

Speakers

Warren Stacey, SVP of Sales, PRISYM ID

Warren Stacey is the SVP of Sales at PRISYM ID, responsible for leading and driving results from the global sales team. He has a detailed knowledge of the auto-ID industry with particular emphasis on label lifecycle management and production techniques.

Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth. His belief in delivering market leading products to gain customer satisfaction is infectious and result’s in PRISYM ID having an enviable blue-chip customer base which is rapidly growing.

Phil Dray, Senior Test and Validation Engineer, PRISYM ID

Phil Dray is Senior Test and Validation Engineer at PRISYM ID, assisting 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 provides onsite training for PRISYM ID’s proprietary software for the Life Sciences industry. 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 PrisymID for 24 years and has contributed though customer service, installation and customer training. He has extensive experience in software test and process planning.

Craig Jones, VP Enterprise Sales Engineering, PRISYM ID

Craig Jones is the Vice President of Enterprise Sales Engineering for PRISYM ID with responsibility for understanding customer needs and industry challenges to drive solutions to improve efficiency, minimise risk, address regulatory requirements and provide new approaches to business systems and processes.

Craig has 15 years of experience delivering validated label lifecycle management solutions to life science and healthcare industries including medical device, Pharmaceutical and clinical trial organisations. His experience includes roles as an industry consultant, in IT management and as a senior manager for global technical support and professional services.

Who Should Attend?

Senior level executives from US & European medical device manufacturing companies involved in:

  • Logistics
  • Quality Assurance (QA)
  • Manufacturing/Operations
  • Information Systems (IS)
  • Information Technology (IT)

Xtalks Partners

PRISYM ID

PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors. PRISYM ID is the market leader in providing validatable world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients.

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