Medical Device managers, engineers, QA personnel, as well as lean program leaders. Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA)which is often redundant, repetitive, and chained together in a cumbersome way?
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
Alignment of the Six Sigma DMAIC approach to CAPA
Applying lean principles to documenting and tracking non-conformances
Applying lean principles to investigating and resolving non-conformances
Applying lean principles to instituting corrective and preventive actions
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents
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.
Compliance4All DBA NetZealous,
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