ENOVIA and Integware invite you to attend an Executive ReceptionDate: Tuesday, December 16, 2020
Time: 4:00 - 7:00 PM EST
Location: Boston Museum of Science
The D'Arbeloff Suite
ENOVIA and Integware invite you to join them for an evening with FDA consultant Lori Carr at the Museum of Science in Boston, Tuesday, December 16, at 4pm. Join us to learn how you can better prepare your organization to achieve compliance in the new regulatory environment, improve design controls to avoid inspection, and learn about the latest Quality by Design and Total Product Life Cycle best practices.
Featured topics will address the following:
- How do you create product development and enterprise-wide collaboration best practices to deliver high quality products and respond effectively to complaints?
- How do you survive an FDA inspection in today's rigorous regulatory environment?
- What do companies have to do to prepare for an inspection?
- How do you respond efficiently and effectively to a 483 FDA Warning Letter?
Spots are limited. Register today!
Email mailto:enovia.info@3ds.com?subject=FDA Reception Registration or call 978-442-2741.
About the Presenters:Lori Carr is an FDA regulatory compliance consultant and has performed numerous quality assurance audits for medical device companies, created and implemented quality systems and provided guidance on quality, regulatory, and compliance issues throughout the world, and assisted manufacturers in handling FDA Warning Letters, under FDA injunction or have had product seized by FDA.
Ray Wodar is the Global Director for the ENOVIA Consumer & Life Sciences Industry Strategy group at Dassault Systemes. Ray has been with DS for 8 years and has more than 14 years experience focused on enterprise PLM software in the areas of Program Management, Document Management, Product Specification Management, Change Management, and Supplier Relationship Management solutions. Ray has collaborated with Procter & Gamble, Johnson & Johnson Consumer Products and other leading innovators in defining the basis for PLM strategies and implementations.
Dave Hadfield joined Integware in 1997 and is currently a Senior Solution Consultant with over 11 years of experience in helping companies deploy Product Lifecycle Management solutions and helping Fortune 500 companies achieve their business goals. For the past 8 years, Dave has focused on medical device companies and implemented multiple global solutions which include change and configuration management, part 11 and part 820 solutions such as CAPA, NCR, complaints and verification and validation and has worked with numerous companies on the planning and implementation of their PLM strategies including Abbott, Johnson and Johnson and GE Healthcare.