Live Webinar Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 90 mins Live Webinar

"Hear By José Mora who is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems"

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.

Description

Life science manufacturing plants 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 systems and separate files 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.

As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in 99.9% of all life science 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 these document systems

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.

This webinar presents a new approach yet is based on solid principles and proven practices.

Areas Covered

•     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 in the areas of:
•     R&D
•     Manufacturing Engineering
•     Design Assurance
•     Quality Assurance
•     Operations
•     Document Control

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

José Mora

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

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