This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. 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. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.
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 will present a fresh new approach based on solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional practices employed in preparing these documents.
Why Should You Attend:
Do you find yourself constantly struggling to create, manage, and maintain all 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 will present a fresh new approach based on solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional practices employed in preparing these documents.
Areas Covered in the Webinar:
- Brief introduction to lean documents and lean configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to CAPA
- 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:
- R&D Staff
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
- Medical Device Managers
- Lean Program Leaders
Course Provider
Jose Mora,
