New! CNYBAC & TDO Manufacturing Workshop: Session I

August 12, 2020
10:00 a.m. - Noon

2020 Manufacturing Workshop Zoom Virtual Series (Free)
Sponsored by TDO, FuzeHub, MedTech, MACNY and CNY Biotech Accelerator, Upstate Medical University

August 12 - 13, 10:00 a.m. - Noon

Session I:  August 12, 10:00 a.m. - Noon

Register in advance for this meeting*:

Overview of FDA (21 CFR 820) Quality Systems Regulations/ISO 13485
Introduction: Michelle Bonn, President and CEO, Compliance Team
Presenters: Jeff Karbin, VP of Sales and Engineering and Regina Fullin, VP of Regulatory Affairs and Quality Assurance, Compliance Team

  • 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
    • Toyota Kata, Five Whys

Don't forget to register also for Session II:  August 13
*After registering, you will receive a confirmation email containing information about joining the meeting.

For any questions, please contact 
Program co-chairs:  James D’Agostino, MEP Center Director and Kathi Durdon, Exec Director, CNYBAC
Program Sponsors: 










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