Documents Quality Systems Compliance 1 FDA Medical Device Quality Systems Compliance.

Slide 1Quality Systems Compliance 1 FDA Medical Device Quality Systems Compliance Slide 2 Quality Systems Compliance 2 Agenda Introductions, Attendance Sign in Domestic and…

Documents 1 GOOD MANUFACTURING PRACTICES IN A QUALITY WORLD Gordon Harnack President, Oracle Consulting Group....

Slide 1 1 GOOD MANUFACTURING PRACTICES IN A QUALITY WORLD Gordon Harnack President, Oracle Consulting Group Tucson, AZ www.fdamaze.com Slide 2 2 The Discussion Plan Definitions…

Documents Crossing the Threshold ( FDA Regulatory Requirements for Medical Device Manufacturers)

Crossing the Threshold ( FDA Regulatory Requirements for Medical Device Manufacturers) DESIGN CONTROLS FDA Medical Device Design Controls Introduction to the FDA Definitions…