Webinars

Upcoming Live Webinars

How to Prepare for EU MDR 2020

Michael Drues
Photo of Michael Drues, Ph.D., Recognized Regulatory Expert, Vascular Sciences
Ph.D., Recognized Regulatory Expert, Vascular Sciences
Maite Llácer
Photo of Maite Llácer, PhD, Director Quality Compliance International, Edwards Lifesciences
PhD, Director Quality Compliance International, Edwards Lifesciences
Angeles Sanfrancisco
Photo of Angeles Sanfrancisco, Manager Quality Compliance International, Edwards Lifesciences
Manager Quality Compliance International, Edwards Lifesciences
Kim Wakeman
Photo of Kim Wakeman, Solutions Engineer, ETQ
Solutions Engineer, ETQ

Date: Wednesday, May 29th, 2019
Time: 11:00 a.m. PST | 2:00 p.m. EST
Sponsored by ETQ
Presenters:
Michael Drues, Ph.D., Recognized Regulatory Expert, Vascular Sciences
Maite Llácer, PhD, Director Quality Compliance International, Edwards Lifesciences
Angeles Sanfrancisco, Manager Quality Compliance International, Edwards Lifesciences
Kim Wakeman, Solutions Engineer, ETQ

In less than one year, the Medical Devices Regulation (MDR) will be fully implemented. As of May 2020, medical device manufacturers that wish to distribute products in the European Union will be required to comply with these new rules. For these organizations, there is a lot to do to prepare in a relatively short time. In this webinar, you’ll learn valuable insight from industry experts and medical device manufacturers on how to be fully prepared for this important regulatory change.

  • Overview of EU MDR regulations timeline and scope
  • Where most organizations stand with their compliance journey today
  • Major areas of the Regulations Annexes
  • EU MDR Product Vigilance
  • Lessons learned and best practices
  • How organizations can determine their readiness

On-Demand Webinars

How to Prepare for FDA Migration

Morgan Palmer
Photo of Morgan Palmer, CTO of ETQ
Chief Technology Officer, ETQ
Ujjal Chakravartty
Photo of Ujjal Chakravartty, Director of Global Quality Systems at Avanos Medical
Director Global Quality Systems, Avanos Medical

Date: Thursday, May 9th, 2019
Hosted by FDA News
Presenters:
Morgan Palmer, Chief Technology Officer, ETQ
Ujjal Chakravartty, Director of Global Quality Systems at Avanos Medical

The FDA is transitioning from the QSR regulation to ISO 13485:2016 for medical devices. In addition, the Medical Device Single Audit Program has gained traction. A single audit system provides many benefits including time and cost savings, less business disruption related to multiple regulatory audits and ease of entry into multiple markets.

The Quality Leader’s Guide to New Product Introduction Success

Dan Jacob
Photo of Dan Jacob, Principal Analyst and Research Director at LNS Research
Principal Analyst and Research Director, LNS Research

Date: Wednesday, March 27, 2019
Hosted by ETQ
Presenter:
Dan Jacob, Principal Analyst and Research Director, LNS Research

Successful new product introduction (NPI) is crucial to achieve corporate goals. But today’s NPI success rate is relatively low largely due to historical NPI challenges combined with market trends including increased visibility to product performance and quality, global pressures, and increasingly complex products. Quality leaders that see deep engagement in NPI as their holy grail may be surprised that the levers for that engagement exist today.

ETQ Reliance 2019: Make Quality Your Competitive Advantage with a QMS Platform for Today's Quality Requirements

Morgan Palmer
Photo of Morgan Palmer, CTO of ETQ
Chief Technology Officer, ETQ
Glen Fraser
Photo of Glen Fraser, Senior Director Solution Architects at ETQ
Senior Director Solution Architects, ETQ

Date: Thursday, March 14, 2019
Hosted by ETQ
Presenters:
Morgan Palmer, Chief Technology Officer, ETQ
Glen Fraser, Senior Director Solution Architects, ETQ

Join industry experts to learn how Quality Management System requirements have evolved to meet today's new era of increasingly stringent quality demands. You'll learn the key drivers in quality and supply chain management today and how those impact a QMS solution’s ability to deliver better business outcomes. You'll hear case study examples and learn how the new ETQ Reliance 2019 makes it easier than ever to build optimal, comprehensive and integrated quality programs that deliver a competitive advantage and ensure a strong brand reputation.

Using Technology to Turn Operational Excellence Vision into Reality

Hosted by ETQ
Presenters:
Ben Riblett, Principal, Quality and Compliance Services, HighPoint Solutions
Tony Parise, Life Sciences Product Manager, ETQ
Greg Stevens, Global Alliances and Channels, ETQ

When one hears the phrase “Operational Excellence” they think process improvement or increasing efficiency in the process. But most companies struggle to turn their Operational Excellence (OPEX) vision into reality. What happens AFTER you design your OPEX program? How do you improve effectiveness and efficiency while maintaining compliance and reducing risk? In this webinar we look to answer those questions by demonstrating how your refined process can translate into an electronic system that can help turn vision into reality.