Navigating Complex Regulations and Complaints to Achieve Quality Compliance for Life Sciences and Medical Devices

Life Sciences, Pharma Manufacturing & Supply Chain, Medical Device, Medical Device Safety and Regulation, Medical Device Manufacturing & Supply Chain,
  • Monday, June 24, 2024

As life sciences and medical device manufacturers strive to scale their operations to meet growing demands in a dynamic landscape, their journey can be full of challenges.

If your organization operates at a broader scale or is seeing business growth, has a deep line of complex products to manufacturer, a huge number of suppliers or is subject to global compliance regulations, it can be even more challenging.

In this session you will learn:

  • The importance of flexible and configurable technology to meet changing requirements
  • How to maintain the drive for continuous improvement in all types of economic and market “weather”
  • How to stay compliant as new products, new markets and new locations are added to the corporate infrastructure on a regular basis.
  • How progressing on your own quality journey can help you stay in front of your competition

Register for this webinar today to gain invaluable insights into overcoming quality compliance challenges in the life sciences and medical device industries.

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Speakers

Kim Wakeman, ETQ

Kim Wakeman, Director, Product Management, ETQ

With more than 20 years of experience working in the medical device industry, Kim Wakeman has worked with ETQ for more than 15 years. During her tenure at a medical device manufacturer, Kim worked in multiple roles in quality assurance, regulatory affairs and IT teams.

She defined/refined, developed, validated and implemented business solutions to streamline processes that were both cost-effective and compliant across multiple business units. Kim directly assisted global management teams in audits conducted by regulatory agencies. Her industry experience has provided her with a valuable understanding of business processes and the best methodology to implement them in the ETQ platform.

Message Presenter
Michael Farrell, Illumina

Michael Farrell, IT Manager, Illumina

Mike Farrell has over 11 years of experience delivering high value solutions for quality teams focused in the life sciences industry. He has been involved in QMS implementations ranging from forward facing solutions for suppliers to internal CAPA programs configuring from the ground up.​ Mike lives in San Diego, CA and enjoys surfing and being in the water, cooking and family time.

Message Presenter

Message Presenter

Have questions or would like more information? Use the form below to send a message.

Who Should Attend?

This webinar will appeal to Managers and above working in the following departments within Quality and/or Quality, Health, Safety and Environment (QHSE) divisions:

  • Quality/QMS/Quality Assurance/Compliance
  • Digital Transformation
  • Supply Chain/Supply/Supplier
  • Continuous Improvement
  • Document Control
  • Regulatory
  • Lean Six Sigma/Process Improvement
  • IT
    • Environmental Health & Safety/EHS
    • Health & Safety/Safety
    • Sustainability
    • QHSE/Quality & Safety

What You Will Learn

This webinar, tailored toward quality professionals, will cover:  

  • Compliance challenges and unique complexities facing the industry such as MedWatch 
  • How to leverage an EQMS for best practices for navigating regulatory challenges and streamlining complaints management while scaling operations to mitigate risk 
  • Lessons learned along the way of achieving successful compliance 

Xtalks Partner

Hexagon_ETQ

ETQ

ETQ, part of Hexagon, is a global leader in integrated quality management, health, safety, and environmental solutions for manufacturers. ETQ delivers a business advantage through quality to enterprise customers spanning industries such as pharmaceuticals, electronics, manufacturing, food and beverage, medical devices and more. Firms rely on ETQ to ensure optimal quality at scale, reduce costs and improve the velocity of data-driven decisions.

Hexagon is a global leader in digital reality solutions, combining sensor, software and autonomous technologies. We are putting data to work to boost efficiency, productivity, quality and safety across industrial, manufacturing, infrastructure, public sector and mobility applications.

Our technologies are shaping production and people-related ecosystems to become increasingly connected and autonomous — ensuring a scalable, sustainable future.

Hexagon (Nasdaq Stockholm: HEXA B) has approximately 24,000 employees in 50 countries and net sales of approximately 5.2bn EUR. Learn more at hexagon.com and follow us @HexagonAB.

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