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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from July 2020.
Quality and regulatory programs have historically functioned
as a cost center for manufacturers of medical devices, pharmaceuticals and
other regulated industries. In this webcast, you will learn how to view the
vital missions of these quality and regulatory business units as a central
strategic initiative that drives new product introduction and expansion to
build market leadership.
The aim is to offer a better understanding of the synergy
between quality and regulatory activities in product development, risk
management, problem-solving, kaizens and quality analytics. Fully grasping this
relationship will help to foster a culture of continuous improvement and to
transform quality and regulatory programs into important profit drivers.
The webcast will conclude with lessons learned from the
COVID-19 pandemic about leveraging risk management and quality management
systems to maximize business success in times of disruption and digital
Intermediate: Content is designed
based upon the assumption that individuals have basic knowledge of the topic(s)
and/or demonstrated competence related to the topic(s). Higher-level concepts
are introduced during lectures; exercises requiring synthesis and/or
application of concepts are incorporated into the activity.
Upon conclusion of the program, you will learn about:
Principles of quality by design and how it
drives business growth
Business synergy between quality and regulatory
programs in drugs and devices
Quality engineering principles in product
development, problem solving, kaizens and quality analytics toolkit
Risk management and lessons learned from the
Quality’s digital transformation
Risk management professionals
Michel Moravia, product manager - quality, ETQ
Michel Moravia, product manager, quality, is a quality
leader and engineering professional with over 10 years of experience in the
biotech and medical device industries. His expertise spans new product
introduction, quality control/quality assurance, and technology and
manufacturing transfer. He has served as a leader for PSP courses and kaizens
for Danaher Corporation and is a certified BSI ISO 13485: 2016 Lead Auditor.
Michel holds a Masters of Science in product design engineering and an MBA from