An Advanced Course on Lean Documents, Lean Configuration and Document Control

Instructor: Jose Mora
Product ID: 701653
  • Duration: 60 Min
This training on lean documents and document control will explain the different types of documents and the usage of lean document principles. Attendees will also learn types of controlled documents; examples of lean and non-lean controlled documents, pros and cons of lean vs. non-lean documents.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Dec-2015

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Areas Covered in the Webinar:

  • 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 for an electronic document system.

Who Will Benefit:

This webinar will provide valuable insights to:

  • Design engineers
  • Manufacturing engineers
  • Operations managers
  • Quality system managers
  • Document control managers
  • Project leaders implementing an electronic document system
  • Functional managers
  • QA managers
  • Lean project managers
Instructor Profile:
Jose Mora

Jose Mora
Principal Consultant, Atzari Enterprises

Jose 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.

Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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