2nd Annual Manufacturing Workshop sponsored by TDO, FuzeHub and CNY Biotech Accelerator

September 16, 2021
8:00 a.m. - 2:45 p.m.

2021 Manufacturing Workshop (Virtual)
Sponsored by TDO, FuzeHub and CNY Biotech Accelerator, Upstate Medical University
Thursday, September 16, 2021   |   8:00 a.m. – 2:30 p.m. EST

Register in advance for this meeting:

8:00 a.m.

Welcome and Introduction





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

Topics include:  Device Classification, A Risk-based Approach; Design Controls; Human Factors, Medical Device Software Validation


Overview of ISO 9001, Quality Management Meeting Customer Requirements
Presenter:  Sarah Burlingame, Senior Project Director, TDO

Topics include:  Design Standard Components; Certifications; Basic Problem Solving Tools to Utilize - Root Cause Analysis, Toyota Kata, Five Whys


Preparing for Manufacturing
Kevin Webb, Business Development, CO-AX Technology


Quick Lunch Break



NYS MEPs/Manufacturing Support-based NYSTAR Assets Panel
Moderator:  Steve Melito, Senior Solutions Specialist, FuzeHub

  • Cory Albrecht, Director, Advanced Institute for Manufacturing, Mohawk Valley Community College
  • Mark Poliks, PhD, Director, Center for Advanced Microelectronics Manufacturing (CAMM), Binghamton University
  • Jim D’Agostino, MEP Center Director, TDO
  • Molly C. Zimmermann, Esq., Managing Director, NYS Science & Technology Law Center
  • Devon Shipp, Professor, Director of the Center for Advanced Materials Processing (CAMP), Clarkson University


Contract Manufacturers Panel
Moderator:   Jim D’Agostino, MEP Center Director, TDO

  • Steve Davis, President, Tapecon, Inc.
  • Michael Allen, President, Z-AXIS, Inc.


Final Program Q&A

For any questions, please contact cnybac@upstate.edu
Program co-chairs:  James D’Agostino, MEP Center Director, TDO; Steve Melito, Senior Solutions Specialist, FuzeHub; and Kathi Durdon, Executive Director, CNY Biotech Accelerator



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