21 CFR Part 820 - Quality System Regulation

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 Configuration
Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
Basic functions found in a life sciences manufacturing plant
Key types of controlled documents and records for manufacturing Quality Management System (QMS) elements controlled via documentation
Bringing it all together

Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents
R&D
Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document 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: +1-800-447-9407
Email: [email protected]

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WHEN AND WHERE

14 March 2017
United States of America

ORGANIZER

Compliance4All

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Added 7 years ago by Compliance4All on Education , Health and Medicine , Food Safety , Medical ethics