- This event has passed.
2020 Manufacturing Workshop Zoom Virtual Series
August 12 @ 10:00 am - 12:00 pmFree
Sponsored by: TDO, FuzeHub, MedTech, MACNY and CNY Biotech Accelerator, Upstate Medical University
Virtual Sessions | August 12 & 13
Overview of FDA (21 CFR 820) Quality Systems Regulations/ISO 13485
Introduction: Michelle Bonn, President & CEO, Compliance Team
Jeff Karbin, VP, Sales & Engineering and Regina Fullin, Director of GxP Compliance Services, Compliance Team, Inc.
- Device Classification, A Risk-based Approach
- Design Controls
- Human Factors
Overview of ISO 9001, Quality Management Meeting Customer Requirements
Sarah Burlingame, Senior Project Director, TDO
- Design Standard Components
- Basic Problem Solving Tools to Utilize: Root Cause Analysis and Toyota Kata, Five Whys