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2020 Manufacturing Workshop Zoom Virtual Series

August 12 @ 10:00 am - 12:00 pm

Free

Sponsored by: TDO, FuzeHub, MedTech, MACNY and CNY Biotech Accelerator, Upstate Medical University

Virtual Sessions | August 12 & 13

Session I: 
Overview of FDA (21 CFR 820) Quality Systems Regulations/ISO 13485
Introduction: Michelle Bonn, President & CEO, Compliance Team
Presenters:

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

Details

Date:
August 12
Time:
10:00 am - 12:00 pm
Cost:
Free
Event Category:
Website:
https://upstate.zoom.us/meeting/register/tJEuduqsqD4pGt2Hy2XtU-3ibyu284d_Hjme

Venue

Online/Webinar