Webinar On "Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration"

Event Details

Time: January 9, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: http://bit.ly/2E5Irrw
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Jan 4, 2018

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Event Description

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.
Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.

Background :

Many companies have outsourced both their design and manufacturing to specialized suppliers. As new medical device technologies push the boundaries of miniaturization, 3D printing and solid modeling, imaging, drug-device combinations, and new applications, the demand for specialized suppliers has left gaps in the common understanding of medical device requirements. Also, changes to ISO 13485:2016 have required a risk-based approach to all QMS processes – including those associated with supplier management and processes associated with them.

Why should you attend - Fear, uncertainty and doubt (FUD) liner for the marketing purpose :

Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world.

Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand what the hands-on challenges of dynamic cross-functional and cross-organizational teams as they push the boundaries of technology and new applications.

This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Areas Covered in the Session :

Review of Lean Documents and Lean Configuration concepts;

Overview of Supplier Quality Management:

Basics of supplier quality management
Issues around design controls and design freeze
Issues around manufacturing and quality metrics
Alignment of supplier to designer/manufacturer
Risk management including risk mitigation
Risks around supplier quality during design changes
Risk Management File and Design History File

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control

About Speaker:

José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects.