- Global Pharma News & Resources
30-Apr-2019 - 30-Apr-2019

Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration


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 present 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 this webinar?

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? Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues? This webinar presents a fresh new approach based on 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:

  • A 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 can Benefit:

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

  • R&D

  • Manufacturing Engineering

  • Design Assurance

  • Quality Assurance

  • Operations

  • Document Control

Speaker Profile:

Jose Mora is Keynote Speaker at ComplianceKey.He is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.


Contact Info:

Compliance Key



Phone: 717-208-8666