How to Speed Innovation at Lower Cost in a Global Regulated Environment
- Created on Wednesday, 11 September 2013
- Friday, 09 August 2013
In this era of groundbreaking science, cutting-edge medical device innovations, a growing and aging population, global manufacturing and emerging markets, there are exciting business opportunities for Medical Device companies.
To support this dynamic environment and adopt best product lifecycle management practices, you need the flexibility and security of a comprehensive, cloud-based Product Lifecycle Management (PLM) solution.
Come hear how a validated, global PLM system can expedite regulatory approval and streamline compliance, help you formalize design and change control processes, and manage your quality documentation across globally dispersed manufacturing teams, reducing risk and avoiding costly shipping delays while accelerating innovation and business results.
In this Webinar we will discuss:
- Expanding Medical Device market opportunities
- Why you need PLM sooner than later
- Simplifying management of DHFs, DMRs, BOMs and change orders
- Managing compliance and streamlining audits
Speaker: Yelena Bolton, Validation Program Manager, Arena Solutions
Yelena Bolton has over 15 years of experience in design verification, validation development, process improvement, and product management including 6 years in medical device FDA regulated environment. Prior to joining Arena Solutions, Yelena was the Project Manager at Boston Scientific and has also worked as a Proton Therapy System Validation Project Manager at Varian Medical & as a Clinical Database & Validation Manager at Accuray, Inc along many others. At Arena Solutions, Yelena is responsible for validation maintenance service and compliance.
Yelena holds a MBA with double concentrations in Finance & Economics from Karazin Kharkiv National University.
Speaker: William Haack, Regulatory Manager, Arthrex
William Haack has over 20 years of experience in Engineering in Endoscopic Video and Product Lifecycle Management (PLM) for document control and retention. William has also architected the pointe conception quality management system for ISO 13485, ISO 9001, and FDA QSRs and has a deep knowledge and understanding of Global Regulatory requirements. Prior to joining Arthrex, William was the VP of Engineering at Pointe Conception Medical and held senior executive positions at Karl Storx Imaging and Medical Concepts.
William holds a BSEE from California Polytechnic State University, San Luis Obispo.