Contract Manufacturing for Quality in the Time of COVID-19

Medical Device, Medical Device Safety and Regulation, Medical Device Manufacturing & Supply Chain,
  • Tuesday, September 29, 2020 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

The dawn of 2020 brought significant changes to everyday life, as well as the way organizations approach manufacturing and quality. With the outbreak of COVID-19, and with an anticipation that this virus will be with us for the foreseeable future, organizations that are able to maintain quality in their manufacturing operations, and adapt to a changing environment, are best positioned to be successful in this new era. While much is changing, the Manufacturing Triangle – Cost, Quality, and Schedule – is not. Supply chains still need to be met and on time; quality documentation must be generated for satisfactory regulatory compliance; agility in manufacturing volume, often relying on contract manufacturers to allow for rapid increases in volume to meet demand, must be attainable.

To achieve these goals for their customers, contract manufacturers are developing new methods of doing day-to-day work and guiding customers through the contract manufacturing cycle. Developing means of doing remote and virtual customer and supplier interactions and audits in both the quality and manufacturing spaces allow customers to understand how the successful contract manufacturer will be able to adhere to quality standards while adapting to rapidly changing market demands, and will both keep workers safe and ensure the end product meets the same quality standards found in a pre-COVID-19 environment. Balancing the many demands and needs in the COVID-19 era allows customers to rapidly bring product to market, without sacrificing quality.

Speakers

http://Dave%20Thoreson,%20Phillips-Medisize

Dave Thoreson, VP Global Operations, Phillips-Medisize

As VP of Global Operations, Dave Thoreson has responsibility for all medical and ENDS focused operations for Phillips-Medisize (MPS). He collaborates with customers to ensure our manufacturing locations, capabilities and quality systems are aligned with our customer expectations and compliant with the FDA regulations and cGMPs.

Dave Thoreson joined Phillips-Medisize in 1996 as a project manager at its Phillips, Wisconsin operation. He was promoted to Engineering Manager in 1999 and then moved to the Menomonie facility as Engineering Manager in January 2003. In February of 2005, Dave was promoted to General Manager of the Phillips-Medisize Menomonie medical site, and shortly thereafter, VP and General Manager. In that role, he was responsible for the sales and operations of the medical sites (including Ireland) that support the Phillips-Medisize medical business. In 2019 he was promoted to his current role as Global VP of Operations.

Message Presenter
http://Cheryl%20Norder,%20Phillips%20Medisize

Cheryl Norder, VP of Quality, Phillips-Medisize

As Vice President of Quality, Cheryl is responsible for the Phillips-Medisize global quality organization for the Medical, ENDS and Commercial business sectors. Cheryl has over 25 years of Medical Device and Pharmaceutical experience and has been with Phillips-Medisize since 1999 in various roles from Quality Manager to her most recent promotion in 2019 to her current position.

She has a bachelor’s degree from Concordia University and a Master’s Degree from Cardinal Stritch University in Management. Cheryl has extensive experience in ISO 9000, 13485, cFDA, MHRA, MHLW, FDA QSR and FDA 210/211. Prior to joining the company, she was a Quality and Validation Manager for PCI in Rockford, Illinois.

Message Presenter

Who Should Attend?

This webinar will benefit senior professionals in the pharmaceutical and medical device industries who are:

  • Quality Managers
  • Product Development Managers
  • Regulatory Compliance Professionals
  • Supply Chain Personnel
  • Engineering Managers

 

What You Will Learn

Participants will learn how successful contract manufacturers are:

  • Adapting quality systems and manufacturing environments to meet customer needs
  • Balancing COVID-19-related changes to regulatory guidance
  • Continuing to meet workplace safety requirements

Xtalks Partner

Phillips-Medisize

Phillips-Medisize, LLC, a Molex company, is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device market segments. Backed by the combined global resources of Molex and its parent company Koch Industries, Phillips-Medisize’s core advantage is the knowledge of its people to integrate design, molding, electronics, and automation, providing innovative, high-quality manufacturing solutions.

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