Lean Supplier Management in Compliance with FDA and ISO-13485 Requirements
Duration : 60 Minutes
Jeff Kasoff,
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff unique Read more
You depend on your suppliers to provide you with goods and services. However, can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all the requirements? Notified bodies and the FDA rely on you to exercise sufficient control over your suppliers. Your supplier management system must ensure that your suppliers meet all the requirements contained in both external regulations and your internal procedures. To assure compliance utilizing a value-added, supplier-appropriate supplier management scheme is the most challenging task.
Your supplier management program can be in compliance; however, is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse, losing them – try explaining that to your supply chain management!
Course Objective:
Join this session, where expert speaker Jeff Kasoff will review the quality systems regulation (QSR) and ISO requirements for supplier evaluation. Jeff will define the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. He will also define the QSR and ISO requirements for supplier assessment. This session will cover the increased focus of ISO 13485:2016 on outsourced processes and risk management.
The session will discuss the application of a risk-based process resulting in a customized supplier management system. You will be able to perform a critical analysis of your current supplier management
Course Outline:
This session will cover:
• Supplier selection
o Review of FDA and ISO requirements
o Types of suppliers that must be qualified
o How to define critical suppliers
o Classification of suppliers
o Outsourced processes
o The quality agreement
o Recommended practices
• Supplier assessment
o Review of FDA and ISO requirements
o Recommended practices
o How to avoid “death by supplier audit”
o Documentation requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Supply chain management
• Buyers
• Purchasing management
• CAPA coordinators
• Regulatory management
• QA management
• Executive management
• Internal auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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