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 transformation. 

Learning Level:

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.

Learning Objectives

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 COVID pandemic

·         Quality’s digital transformation

Who Should Attend

·         Quality professionals

·         Regulatory professionals

·         Compliance managers

·         Risk management professionals

 

Speaker:

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 Boston University.