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Consultant Biography

Typical Client Results

Reprints

"You can rely on it," J. C. Stephens, APICS The Performance Advantage, January (2003)
"When do design controls start?" J. C. Stephens, Regulatory Affairs Focus, February (2003).
"Effective Risk Assessment," J. C. Stephens, Regulatory Affairs Focus, March (2003).
"Improving Visual Inspection," J. C. Stephens, Manufacturing Engineering, April (2003).

Forms, Checklists, and Guides

Good Documentation Practices Quick Reference Guide

Generic Calibration Form

Generic Complaint Investigation Form

Generic Complaint Log

Computer System Validation Documentation Checklist

Generic Corrective / Preventive Action Form

Generic Design Review Form

Generic Design Failure Mode and Effects Analysis (DFMEA) Spreadsheet

Document Review Checklist

Generic Engineering Change Request Form

Generic Inspection Form

Installation Qualification Checklist

Generic Internal Audit Form

Generic Managment Review Form

Generic Raw Material Traceability Form

Generic Preventive Maintenance Form

Generic Quality Plan

Generic Medical Device Servicing Form

Generic Training Form

FDA Documents

Recommended Books

The FDA Worldwide Quality System Requirements Guidebook for Medical Devices, Amiram Daniel & Ed Kimmelman, ASQ Press (2008)

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