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

 
  January 16, 2015  
     
 


Compliance Trainings, Online
2015-02-18


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 presents 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:

Research & Development

Design Assurance

Quality Assurance

Operations

Document Control

Manufacturing Engineering

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : 4169154458 
Email : support@compliancetrainings.com

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

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. 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. José 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. José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

 
Deadline for Abstracts: 2015-02-18
 
Registration:

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

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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