GlobalCompliancePanel to organize RAPS pre-approved webinar on "Incorporating Six Sigma DMAIC into CAPA

(prHWY.com) August 24, 2012 - Wilmington, DE -- Description:
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are the integral units of the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Although they are documents without which compliance cannot be achieved; they are often confusing in their wording and requirement of processes. As a result, compliance professionals end up doing the same things over and over and still facing the same set of problems repeatedly, although they have adhered to the process. In fact, they face this situation only because they have followed prescribed processes, and not because they have been skipping any.
A commonsensical way out of the muddle is to incorporate Lean Six Sigma DMAIC into the CAPA of these records. This will ensure that redundant process can be sidestepped. The result is a DHF, DMR and DHR process that is transparent and clutter-free. At the webinar, the expert will impart his knowledge of having worked with the industry for about three decades.
This session will enable participants to put reliable processes and systems in place. These are the areas covered in this session:
o Brief introduction to Lean Documents and Lean Configuration
o Quality System Regulation, 21 CFR Part 820, as it applies to CAPA
o The Six Sigma DMAIC process
o Types of Corrective and Preventive Actions
o Integration of DMAIC into the CAPA process
o Examples
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When: September 13, 10:00 AM PDT | 01:00 PM EDT
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By whom:
JosÃ© Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For three decades, he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi Techniques, Theory of Constraints, Lean Manufacturing, Five S's (Visual Workplace), process validation to GHSS standards, and similar approaches.
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For whom:
The webinar will benefitManagers, Supervisors, Directors, and Vice-Presidents in the areas of:
o R&D
o Manufacturing Engineering
o Quality Assurance
o Operations
o Document Control
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Duration:60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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