Supplier Management: Overcoming Challenges and Exploring Opportunities
Learn FDA QSR and ISO requirements for selecting and assessing suppliers, how to classify critical suppliers and outsourced processes, and how to build a risk-based program.
Speaker
Jeff Kasoff
Quality and regulatory consultant · Lean to Quality, LLC · 30+ years in quality and regulatory
Overview
The FDA and notified bodies cannot hold your suppliers to the quality system regulations, so they expect you to control those suppliers yourself, especially the critical ones. This supplier management webinar explains how to build a program that meets those expectations.
You'll review QSR and ISO requirements for supplier evaluation, including which types of suppliers need to be evaluated, how to define critical suppliers and how to handle outsourced processes. The requirements for supplier assessment are covered as well.
The session also looks at quality agreements, documentation and how to apply a risk-based process so your supplier management system fits your company instead of becoming a burden.
Why attend: You rely on suppliers for goods and services, but can your system prove to auditors and regulators that you control them well enough to keep your product safe? A compliant program can still be costly if overhead runs out of control, and being too demanding can alienate or even lose suppliers. This session suits regulated companies that want a compliant, cost-efficient program, including supply chain, purchasing, buyers, CAPA coordinators, regulatory, QA and executive management, and internal auditors.
What’s covered
- Review of FDA and ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Classifying suppliers
- Outsourced processes
- The quality agreement
- Recommended practices
- Review of FDA and ISO requirements
- Recommended practices
- How to avoid "death by supplier audit"
- Documentation requirements
Who should attend
What you get
About the speaker
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He 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 uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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