Design Inputs Design Outputs Traceability Matrix - 2017

Overview:
If your design and manufacturing resources are spending too much time on

documentation and not enough time on actual design and manufacturing you

as a manager need to be looking for ways to simplify their work.

Areas Covered in the Session:
Brief introduction to Lean Documents and Lean Configuration.
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to

design control documents.
Traceability Matrix.
Applying lean document and lean configuration principles to the above.
Bringing it all together

Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents
R&D
Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document Control

Speaker Profile:
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering

and Quality Systems. For over 30 years he has worked in the medical device

industry specializing in manufacturing, process development, tooling, and

quality systems. Prior to working full time as a consulting partner for Atzari

Consulting, José served as Director of Manufacturing Engineering at Boston

Scientific and as Quality Systems Manager at Stryker Orthopedics, where he

introduced process performance, problem solving, and quality system

methodologies.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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