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.
One of the most pressing concerns is navigating customer complaints and regulatory requirements. For example, between 2021 and 2023, the top three citations from the US Food and Drug Administration (FDA) for medical devices were related to lack of or inadequate procedures, complaint procedures and nonconforming products.
In this webinar, the attendees will gain insights into:
- Understanding compliance challenges and unique complexities facing the industry such as MedWatch, the FDA’s medical product safety reporting program
- Leveraging an enterprise quality management system (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
Register for this webinar today to gain invaluable insights into overcoming quality compliance challenges in the life sciences and medical device industries.
Speakers
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
Angel Bruzos, Business Analyst III - eQMS and Corporate Applications, Applied Medical
Angel Bruzos is a Lean Six Sigma Black Belt professional with over 15 years of experience within the FDA Class III Medical Device Environment. He leads mission-critical process improvement through design, validation and cross-site implementation for flagship product lines of market leaders, including Edwards Lifesciences and Abbott Vascular.
Within Applied Medical, he has held senior/principal positions in various functions, including Quality Engineer (Operations Support), Manufacturing Engineer, Design Assurance Engineer, Technical Supervisor (Operations), and now Lead Business Analyst for eQMS Implementation Portfolio.
He is currently serving as EtQ SME – key architect, product owner (SCRUM) and administrator while performing as business liaison with internal customers of the Quality System and Regulatory teams. He is responsible for expanding the feature set of our eQMS ecosystem to support ongoing and expanding operations while ensuring compliance to the ever-growing set of regulatory requirements and standards.
Message PresenterWho 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
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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