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21 CFR Part 820 - Quality System Regulation

Start Date:
Tuesday, 14 March, 2017
End Date:
Tuesday, 14 March, 2017 11:00am
Health & Nutrition

Overview: In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820. Why Should you attend:If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

Areas Covered in the Session:Brief introduction to Lean Documents and Lean ConfigurationQuality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documentsBasic functions found in a life sciences manufacturing plantKey types of controlled documents and records for manufacturingQuality Management System (QMS) elements controlled via documentationBringing it all together Who Will Benefit:Managers, Supervisors, Directors, and Vice-PresidentsR&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument Control Speaker Profile:Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems.

For over 30 years he has worked in the medical device 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. Contact Detail: Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

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