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]