The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) 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.
Do you find yourself constantly struggling to create, manage, and maintain all of the information found in the documents of a typical QMS – 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 documentation and not enough on design, manufacturing, and supplier management?
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.
Areas to be Covered:
Brief introduction to Lean Documents and Lean Configuration
Quality System Regulation, 21 CFR Part 820, ISO 13485, ICH Q10 Pharmaceutical Quality System
Key elements of a Quality Management System (QMS)
Applying lean principles to medical device QMS documents
Applying lean principles to pharmaceutical QMS documents
Who will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Lean Program Leaders