Call us at +1-(510)-868-1040

Login Register

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.


The objectives of the presentation are:

  • Brief introduction to Lean Documents and Lean Configuration
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents


If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use. 

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. This webinar presents a new approach yet is based on solid principles and proven practices. 


  • Traceability Matrix
  • Applying lean document and lean configuration principles to the above
  • Bringing it all together


Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control


José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development, and quality systems, having lectured internationally and presented webinars on these subjects.

For over 30 years he has worked in the life sciences in positions ranging from Senior Engineer and Project Manager to Vice-President, specializing in manufacturing, process development, tooling, and quality systems. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

Irrespective of the places he worked, Jose has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches. He has implemented various good manufacturing practices like JIT, kanban systems, visual workplace, and lean manufacturing practices. He has also published a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

View all trainings by this speaker
 
On Demand

Transcript

PDF Transcript of the Training which are available once the webinar is completed.(Transcript for single user only)

$179

Downloadable recorded session

Get unlimited access to the link for six months.

$239

Training CD

Free shipment within 72 Hours, from the date of webinar completion.

$350

  

Upcoming Webinars