Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT Duration : 60 Minutes 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, yet is based on solid principles and proven practices.

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Webiar Description:
Areas Covered in the Session :
Who Will Benefit:
Speaker Profile:
methodologies. 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 (Visual Workplace), process
validation to Global Harmonization Task Force standards, and similar approaches.
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of
control, via controlled documents and objective evidence in the form of records.
Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to
ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up
instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by
controlled records.
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.
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, yet is based on solid principles and proven practices.
To register for this webinar please visit our website www.compliancetrainings.com
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
Wednesday, July 24, 2013
Duration : 60 Minutes
10:00 AM PDT | 01:00 PM EDT
Speaker | José Mora
> 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
To register for this webinar please visit our website www.compliancetrainings.com
All Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
> R&D
> Design Assurance
> Quality Assurance
> Operations
> Document Control
> Manufacturing Engineering
21 CFR Part 820 - Quality System Regulation -
Applying Principles of Lean Documents and Lean Configuration