Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Website https://compliance2go.com/product/?pid=CP2014-388 | Edit Freely

Category Biotechnology , Medical Device

Deadline: November 19, 2014 | Date: November 19, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-10-16 15:40:38 (GMT+9)

Call For Papers - CFP

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.

Why should you attend:

If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

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.

This webinar presents a new approach yet is based on solid principles and proven practices.

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 in the areas of:

R&D

Manufacturing Engineering

Design Assurance

Quality Assurance

Operations

Document Control

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance