Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration training seminars presented by ComplianceOnline register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration  

 Email information about this seminar Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration by ComplianceOnline to yourself your manager or associates Email this event... View and register for other training seminars like Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration by ComplianceOnline on FindaSeminar.com Find similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

Senior quality managers, Quality professionals, Regulatory professionals,Compliance professionals, Production supervisors, Manufacturing engineers, Production engineers, Design engineers, Process owners, Quality engineers, Quality auditors

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

During this seminar, the Theory of Lean Documents and its corollary applied to lean configuration will be applied in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing. (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Design+History+Files+Device+Master+Records+Quality+Management+Systems+QM+Medical+Device+Lean+Documents+Configuration+Compliance training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration seminar

 

 

Training Course Syllabus:


Course Description

The nature of documents that govern the design and manufacturing of medical devices are often redundant, repetitive, and cumbersome, and do not work well as a business process to properly support and realize the gains made in lean manufacturing.
Design History Files (DHFs), Device Master Records (DMRs), and Device History Record (DHRs) are examples of three documents and files that are very closely related, yet create many problems and inconsistencies in their management, preparation, use, storage, and retrieval.
The information found in Design Input Design Output traceability matrices often must be repeated in other documents in a way that creates the risk of errors or inconsistencies. These lead either to excessive non-value-added waste, or even worse, deficient products and processes.
Medical device 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 in controlled records.
This seminar presents a new approach that is based upon solid principles and proven practices. During this seminar, the Theory of Lean Documents and its corollary applied to lean configuration will be applied in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing.

Learning Objectives:

Upon completing this course participants should:
Understand the fundamental Principles of Lean Documents and Lean Configuration
Understand how to construct Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods
Understand how to construct a Design Input Design Output traceability matrix using lean documents and lean configuration methodologies
Prepare a Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
Preparing and managing a CAPA system using lean documents and lean configuration methods

Topic Background:

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

DAY 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction and overview of the principles of lean documents and lean configuration
Overview of 21 CFR Part 820 and where the elements of lean documents and lean configuration may be applied
Detailed description and examples of elements for lean documents and lean configuration
Construction of a Design History File (DHF) using lean documents and lean configuration
Construction of a Device Master Record (DMR) using lean documents and lean configuration
Construction of a typical Device History Record (DHR) template using lean documents and lean configuration
Bringing the above together
Configuration of the above in an electronic system as an alternative to paper documents

DAY 02(8:30 AM - 4:30 PM)

Recap of lean documents and lean configuration elements
Construction of a Design Input Design Output traceability matrix using the principles and methods of lean documents and lean configuration
Typical documents used in manufacturing medical devices using lean documents and lean configuration methods
Examples of CAPA using lean documents and lean configuration methods
Creation of Quality Management System (QMS) Master Record and typical QMS documents using lean documents and lean configuration methods

Seminar Summary:

During this seminar, the Theory of Lean Documents and its corollary applied to lean configuration will be applied in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing. (see full course description)

print this agenda print agenda for the Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration training seminar

 view dates and locations for this seminar

 

 

 

Custom Search