Best practices for purchasing and supplier controls in the medical device industry
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations
- QSR and ISO 13485 requirements for supplier selection and assessment
- How to qualify new suppliers in a cost efficient manner
- This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices
- How to assess current suppliers in a cost efficient manner
- How to perform supplier-related corrective action
- Minimum documentation requirements for supplier qualification, assessment, and related corrective action.
This webinar will provide valuable assistance to all regulated companies that are interested in incurring less cost on supplier evaluation and assessment.
- Purchasing Management
- Regulatory Management
- QA Management
- Consultants
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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