Manufacturing processes have to function in tandem to produce a product. In the same manner, a sound, well-coordinated business process leads to the establishment of controlled documents. Extending the analogy further, if in manufacturing, lack of components can become an impediment for finishing a product; lack of information or its diversion into other documents becomes the logjam for a document. Most life science companies realize the role and value of lean manufacturing, lean laboratory, and lean operations, but are usually lax when it comes to maintaining controlled documents and systems.
This is not to devalue the importance of these other lean practices, but most companies in this sector seem to overlook the importance of putting a lean document practice in place, little realizing that this is of inestimable importance in cutting down operating expenses. Most life sciences companies, even well-established ones, seldom realize that the absence of lean documentation hampers the introduction of process improvements in a timely and effective manner.
Understanding of how to adapt lean documentation practices for the life sciences field
This webinar is all about how lean documentation can add enormous value to your organization. In what is sure to be the best explanation of lean documents you can hear, Angela will explain the importance of lean documentation threadbare and show how to implement lean documents and lean document control that both cut costs and ensures compliance with regulatory authority requirements.
Angela, who brings an astounding four decades of experience in the Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds areas, will show the immense benefits of lean documentation practices for the life sciences industry.
At this webinar, she will cover the following areas:
- Definition of lean documents
- What’s wrong with traditional document approach
- Theory of Constraints and Lean Manufacturing
- Applying lean manufacturing principles to Document Control
- Applying Theory of Constraints
- Examples of various types of lean documents
- Design History File
- Device Master Record
- Device History Record
- Typical challenges and how to overcome them
- Preparing for an electronic document system
This session will be of value to Design Engineers, Manufacturing Engineers, Operations Managers, Document Control Managers, Lean Project Managers, IT staff that implements Electronic Quality Control, and those in Purchasing, Quality Assurance and Document Systems.