Webinar On 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

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Contact Us 416-915-4458
Webinar On 21 CFR Part 820 - Quality System
Regulation - Applying Principles of Lean
Documents and Lean Configuration

Presented By Jose Mora
Scheduled On  Friday, April 24, 2015 at 1300
Hrs
Hosting By Compliance Trainings
Please visit us at https//compliancetrainings.co
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21 CFR Part 820 - Quality System Regulation -
Applying Principles of Lean Documents and Lean
Configuration
Product Id
MD1482
Category
Medical Devices
Friday, April 24, 2015 at 1300 Hrs
Scheduled On
Duration
90 Minutes
Speaker
Jose Mora
Login at https//compliancetrainings.com/si
teengine/Login.aspx
Webinar Description
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.
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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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Speaker Profile
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 Iowas
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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tDetailView.aspx?idMD1482
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