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Complimentary ON-DEMAND Webinar RECORDING

Recorded on October 6, 2022 | 12:00 p.m. - 1:00 p.m. ET

Why a Product-Centric Approach to Quality Matters

It’s critical for companies, especially medical device companies, to evaluate their systems and processes to ensure collaboration across their teams and supply chain partners.

With material shortages, plant shutdowns, economic unrest, and increasing natural disasters, how do medical device manufacturers get safe products to market quickly? Coordinating the efforts of multiple teams, often spread across the globe, can be a daunting task even under normal circumstances. When business is disrupted, companies must take quick steps to ensure that product work continues in a fast, efficient, and compliant manner. A product-centric approach to quality management can help optimize processes across all teams and ensure commercialization and compliance success. Hear from a panel of industry experts with in-depth experience bringing FDA-regulated products to market and know what’s needed to meet product development, quality, and compliance goals despite today’s obstacles.

What You Will Learn: 

  • Biggest challenges to bring medical device products to market
  • What systems and processes should be evaluated to deal with today’s environment
  • What is a product-centric approach to quality and how does it help deliver high-quality and compliant products to market faster
  • Tips for improving new product development processes in an FDA-regulated environment

SPEAKERS

Catie Jelinski
Life Sciences Marketing Sr. Manager
ARENA, A PTC Business

Catie Jelinski has over 25 years of experience in quality and document control at various global medical device companies. She has been involved in configuration management and PLM for over 10 years as a business owner and administrator. Corrective and Preventive Action (CAPA) is her favorite element of the quality management system (QMS).

Mike Keer

Michael Keer
Founder & CEO
Product Realization Group

Michael Keer has over 30 years of experience bringing medical devices, clean technology, consumer electronics, and industrial products to market. As founder of the Product Realization Group (PRG), Mike helps guide the world’s most innovative companies to accelerate the delivery of their products, from concept to full market scale. Mike shares his expertise through mentoring and lectures at universities and industry events.

Angenette Nordqvist
Director, Quality Assurance
SomaLogic

Angenette Nordqvist has over 24 years of experience in Quality Assurance, Quality Control, Lean Six Sigma and Supply Chain. She has spent most of those years in the healthcare industry and recently spent time in the automotive industry. Angenette was a Captain in the U.S. Army Reserves and she learned as a lieutenant, the power of well-defined processes, roles & responsibilities. Angenette earned her Masters in Business Administration from the Leeds School of Business at the University of Colorado in Boulder and is certified by the American Society of Quality (ASQ) as Manager of Quality and Organizational Excellence (CMQ/OE) and also is a Certified Medical Device Auditor (CMDA). She is a Certified Master Black Belt from General Electric. Angenette is currently the Quality Director at Somalogic Operating Co., Inc., an organization empowering transformative research and healthcare with the power of proteomics.

Inga Hansen

Inga Hansen
Managing Editor
MedTech Intelligence

Inga Hansen is the managing editor of MedTech Intelligence and Food Safety Tech. She has more than 20 years’ experience in business-to-business healthcare media. Inga previously served as executive editor of MedEsthetics magazine and associate editor of Dialysis & Transplantation. 

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