JOSE IGNACIO MORA


Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant
Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant
: Jose Ignacio Mora
: 16 January 2019
: 01 : 00 PM EST
: 90 Minutes

A medical device or biotechnology startup plant needs to have product available yet be agile enough to respond quickly to demand and design changes without wasting excess inventory, especially from obsolete products that did not pan out. This webinar explains how to set up and use kanbans all the way from Purchasing and Procurement, to Receiving, Receiving Inspection, Component Stock, Work Order Picking/Sta.....

$179.00
An Advanced Course on Lean Documents, Lean Configuration and Document Control
An Advanced Course on Lean Documents, Lean Configuration and Document Control
: Jose Ignacio Mora
: 31 January 2019
: 01 : 00 PM EST
: 90 Minutes

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 i.....

$179.00
Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration
Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration
: Jose Ignacio Mora
: 07 February 2019
: 01 : 00 PM EST
: 90 Minutes

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.Many companies have outsourced both their design and manufacturing to specialized suppliers. .....

$179.00
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
: Jose Ignacio Mora
Recorded Webinar

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus.....

$200.00
IEC 62304 for Medical Device Software
IEC 62304 for Medical Device Software
: Jose Ignacio Mora
Recorded Webinar

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no.....

$200.00
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