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