Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices
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In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; Types of controlled documents; examples of lean and non-lean controlled documents; Pros and cons of lean vs. non-lean documents.
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance. It will help you understand applying lean manufacturing principles, theory of constraints, DHF, DMR, DHR and how to create a lean DHF, DMR, DHR.
Areas Covered in the Session :
- Definition of lean documents.
- Problems with traditional document approach.
- Applying lean manufacturing principles.
- Applying Theory of Constraints.
- Design History File.
- Device Master Record.
- Device History Record.
- Typical challenges and how to overcome them.
- Examples of various types of lean documents.
- Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
- How traditional document approach generates waste.
- Clues from Theory of Constraints and Lean Manufacturing.
- What a lean document approach would have.
- Creating a lean Design History File.
- Creating a lean Device Master Record.
- Creating a lean Device History Record.
- Preparing to configure an electronic document system.
Who Should Attend:
- Research & Development
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
- Lean Program Leaders
- Project leaders implementing an electronic document system
Course Director: JOSÉ MORA
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