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.

Supplier Quality Management presents the challenges of working through external parties to achieve internal organization objectives.

Course Objectives:

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.

It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.

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.

If you are already 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, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use.

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.

Course Outline:

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
• Lessons learned

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control