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Webinar on Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration

 
  March 04, 2016  
     
 


Compliance Trainings, Online
2016-03-09


Description :

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) - which is often redundant, repetitive, and chained together in a cumbersome way?

Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues?

This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these 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 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.

Areas Covered in the Session :

Brief introduction to Lean Documents and Lean Configuration

Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to Corrective and Preventive Action

Alignment of the Six Sigma DMAIC approach to CAPA

Applying lean principles to documenting and tracking non-conformances

Applying lean principles to investigating and resolving non-conformances

Applying lean principles to instituting corrective and preventive actions

Who Will Benefit:

A must-attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

R&D

Design Assurance

Quality Assurance

Operations

Document Control

 

Manufacturing Engineering

 
 
Organized by: Compliance Trainings
Invited Speakers: 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
 
Deadline for Abstracts: 2016-03-09
 
Registration:

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1488

 

To register this webinar

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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