José Mora speaker of compliance global

18
Tuesday
April, 2017

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700701

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

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.

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José Mora speaker of compliance global

13
Wednesday
May, 2015

Speaker: José Mora
Duration: 60 Minutes
Product ID: 700068

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A Fresh Approach to Controlled Document System using Principles of Lean Documents and Lean Configuration.

All life science industry 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.

Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, standard operating procedures, set-up instructions, equipment maintenance, and support function and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences.

As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in 99.9% of all life science companies. The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these document systems.

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José Mora speaker of compliance global

05
Tuesday
May, 2015

Speaker: José Mora
Duration: 75 Minutes
Product ID: 700082

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Corrective and Preventive Action utilizing the theory of Lean Documents.

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artefacts of a flawed approach. Document management systems present a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

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José Mora speaker of compliance global

29
Wednesday
April, 2015

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700059

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Creation of Unique DHFs, DMRs, and DHRs using the Principles of Lean

The Theory of Document Management system is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

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José Mora speaker of compliance global

08
Wednesday
April, 2015

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700041

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Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design control process involves 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 process and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.

In this webinar, we apply the Theory of Lean process and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.

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José Mora speaker of compliance global

25
Wednesday
March, 2015

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700027

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21 CFR Part 820 - Applying Principles of Lean Documents and Lean Configuration

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.

Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control.  These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.

As is often the case, automation and computers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in the overwhelming majority of medical device companies.  The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

In this webinar, we apply the Theory of Lean process improvement and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820.

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