Overview
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
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 upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.
Webinar Takeaway
- 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
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
José Mora
Principal Consultant, Atzari Consulting, LLC
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time, he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
1.5 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
