- Speaker : José Mora
- Session Code : JMSEP2121
- Date : 21st September 2021
- Time : This Event is Over and the Recorded Copy is Available
- Duration : 1 Hour 30 Mins
21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration
Overview:
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.
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.
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
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
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. 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.
Who
Will Benefit:
Managers,
Supervisors, Directors, and Vice-Presidents in the areas of:
R&D
Manufacturing
Engineering
Design
Assurance
Quality
Assurance
Operations
Document Control
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.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.
His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. 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.
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Tags: jose, mora, 21, CFR, Part, 820, quality, systems, webinar, September, 2021, lean, configuration, documents