Description :Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.Areas Covered in the Session :Brief introduction to Lean Documents and Lean ConfigurationQuality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documentsTraceability MatrixApplying lean document and lean configuration principles to the aboveBringing it all togetherWho Will Benefit:Managers, Supervisors, Directors, and Vice-Presidents in the areas of:Research & DevelopmentManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument Control