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.

1. Webinar On 21 CFR Part 820 - Quality System
Regulation - Applying Principles of Lean
Documents and Lean Configuration
Presented By Jose Mora
Contact Us: 416-915-4458
Hosting By
Compliance Trainings
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Scheduled On : Friday, April 24, 2015 at 13:00 Hrs

2. Contact Us: 416-915-4458
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Webinar Description:
21 CFR Part 820 - Quality System Regulation - Applying
Principles of Lean Documents and Lean Configuration
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.
Prior to computer systems and databases, managers and quality personnel created
complex visual numbering schemes, cross-referencing methods and complex
filing systems for purposes of retrieval and control. These grew over the years
into the extremely complex and convoluted systems we find today throughout the
life sciences, including the medical device industry.
As is often the case, automation and computers do not always replace the legacy
methods, policies, and rules that were necessary with manual and paper systems
but are now obsolete.
Product Id MD1482
Category Medical Devices
Scheduled On Friday, April 24, 2015 at 13:00 Hrs
Duration 90 Minutes
Speaker Jose Mora
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3. Unfortunately, that is the case in the overwhelming majority of medical device
companies. The benefits of automation and information retrieval systems are
not fully realized due to the legacy policy constraints that still hamper them.
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.
If your design and manufacturing resources are spending too much time on
documentation and not enough time on actual design and manufacturing you as
a manager need to be looking for ways to simplify their work.
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.
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 :
All Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Design Assurance
Quality Assurance
Operations
Document Control
Manufacturing Engineering

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@ 416-915-4458
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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.
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