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2020 Manufacturing Workshop

August 13 @ 11:00 am - 5:00 pm

Sponsored by TDO, FuzeHub and CNY Biotech Accelerator
Thursday, August 13, 2020 – 11:00 a.m. – 5:00 p.m.
CNY Biotech Accelerator Theater, 3rd Floor, 841 E. Fayette St., Syracuse, NY

11:00 a.m. Sign-in / Box Lunch

11:30 a.m. Welcome and Introduction: Kathi Durdon, CNY Biotech Accelerator, Jim D’Agostino, TDO

11:45 a.m. Overview of FDA (21 CFR 820) Quality Systems Regulations/ISO 13485: Michelle Bonn, Guideline Medical

  • Quality Management Systems for Medical Device Overview
  • Device Classification, A Risk-based Approach
  • Design Controls
  • Human Factors

1:00 p.m. Overview of ISO 9001, Quality Management Meeting Customer Requirements: Sarah Burlingame, TDO

  • Design Standard Components
  • Basic Problem Solving Tools to Utilize:
    • Root Cause Analysis
    • Toyota Kata, Five Whys

2:15 p.m. Design for Manufacturability: Scott Laundry, TDO

  • Basic Understanding of Manufacturing Processes and Materials
  • Matrix Approach
  • Translating Voice of Customer (VOC) into Quantifiable Specifications
  • Case Studies

3:30 p.m. Rapid Prototyping and 3D Printing: Michael Mowins, Vetted Tech

  • Machine and Material Capability
  • Design for Manufacturing with 3D Printing Changes the Rules
  • Vendor Viewpoint
  • Coordinating with Contract Manufacturers


Free Parking in Lot located behind CNYBAC




August 13
11:00 am - 5:00 pm


CNY Biotech Accelerator Theater
3rd Floor, 841 E Fayette St
Syracuse, NY United States
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