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MANUFACTURING WORKSHOP SPONSORED BY TDO, FUZEHUB AND CNY BIOTECH ACCELERATOR

September 16: 8:00 am - 3:00 pm

2nd Annual 2021 Virtual Manufacturing Workshop 
Hosted by TDO, FuzeHub and CNY Biotech Accelerator, Upstate Medical University
Thursday, September 16, 2021   |   8:00 a.m. – 3:00 p.m. EST

REGISTER IN ADVANCE FOR THIS WORKSHOP HERE>>

Program co-chairs:  James D’Agostino, MEP Center Director, TDO; Steve Melito, Senior Solutions Specialist, FuzeHub; and Kathi Durdon, Executive Director, CNY Biotech Accelerator

AGENDA

8:00 a.m.

Welcome and Introduction

8:10 

 

 

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

9:45

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

11:15 

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

Noon 

Quick Lunch Break

12:15 

 

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

  • 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

1:15 

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

  • Steve Davis, President, Tapecon, Inc.
  • Michael Allen, President, Z-AXIS, Inc.
  • Matt Nearpass, Director, EMS, SRC Tec
  • Michael Fisher, Director of Product Development, Global Center for Medical Innovation

2:15 

Mini Manufacturing Pitch

  • Matt Nearpass, SRC Tec
  • Steve Davis, Tapecon, Inc.
  • Jason DiBartolo, Oswego Industries
  • Benson Chan, Integrated Electronics Engineering Center (IEEC), Binghamton University
  • Doug Hill, LeMoyne Maker Space
  • Scott Baxter, PEKO

 For questions, please contact cnybac@upstate.edu

 

 

 

Details

Date:
September 16
Time:
8:00 am - 3:00 pm
Event Categories:
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Funding Partners