Webinar On - Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration

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.

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.

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 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:

A must-attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

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