Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Who will Benefit

This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers  

  • Project leaders implementing an electronic document system 
  • Functional managers 
  • QA managers 
  • Lean Project Managers 

Webinar Takeaway

  • 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.


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.

Why Should You Attend

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. 

Industries who can attend

This 90 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Jose Mora

Faculty Jose Mora

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

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