Webinar On "Corrective and Preventive Action utilizing the principles of Lean Documents and Lean Configuration"

Event Details

Time: February 7, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: http://bit.ly/2BIok0o
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Jan 31, 2018

Export to Outlook or iCal (.ics)

0 members like this

Event Description

Description :

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

Why should you attend :

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 DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas Covered in the Session :

Brief introduction to Lean Documents and Lean Configuration
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to Corrective and Preventive Action
Alignment of the Six Sigma DMAIC approach to CAPA
Applying lean principles to instituting corrective and preventive actions

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

R&D
Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document Control

About Speaker:

José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects.