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

8:00 a.m.

Welcome and Introduction

8:10–9:45

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

9:45–11:15

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–Noon

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

Noon–12:15

Quick Lunch Break

12:15–1:15

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

1:15–2:15

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

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

2:15–2:45

Final Program Q&A