Description 

The Theory of Lean Documents is about using lean thinking to improve how we create, design, and manage important documents in industries that are heavily regulated, including those that require strict CAPA (Corrective and Preventive Action) processes. Just like lean principles help streamline operations by cutting out waste, traditional document methods—especially around CAPA—are often outdated and inefficient. Lean documents offer a new approach, making CAPA documentation and other processes faster and smoother, while still relying on proven strategies. Lean configuration takes this further by using software to handle tasks that used to be managed through physical paperwork, saving time and reducing the complexity of CAPA and other controlled documents.

What you'll learn?

• Brief introduction to Lean Documents and Lean Configuration
• Regulatory Frameworks: Understand the implications of Quality System Regulation (21 CFR Part 820) and ISO 13485 on CAPA. We’ll discuss how these regulations can be effectively integrated with lean methodologies to enhance compliance
• Alignment of the Six Sigma DMAIC approach to CAPA: Explore the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) approach and its alignment with CAPA processes. This alignment can significantly enhance the effectiveness of your corrective and preventive actions
• Documenting Non-Conformances: Learn how to apply lean principles to document and track non-conformances efficiently
• Investigating Non-Conformances: Discover strategies for resolving non-conformances through streamlined investigation processes
• Instituting CAPA: Gain insights into implementing corrective and preventive actions using lean methodologies to reduce redundancy and improve outcomes
• 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.

Who should attend?

This webinar is ideal for managers, supervisors, directors, and vice-presidents in:

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