Both the QSR and ISO standards require supplier qualification and assessment, and many medical device companies spend a lot of time and money to comply. Many could spend much less and still keep control of their suppliers and stay compliant.
This 60-minute medical device supplier controls training reviews the QSR and ISO 13485 requirements for selecting, evaluating and assessing suppliers, and offers cost-efficient, equally compliant alternatives to many common practices.
You'll learn how to qualify new suppliers and assess current ones efficiently, how to handle supplier-related corrective action, and the minimum documentation needed for qualification, assessment and corrective action.
WHY SHOULD YOU ATTEND?
Supplier evaluation can absorb a large share of quality resources. This webinar helps regulated companies lower the cost of supplier evaluation and assessment without losing control or compliance.
It suits purchasing, regulatory and QA managers and consultants.
AREA COVERED
- QSR and ISO 13485 requirements for supplier selection and assessment
- Qualifying new suppliers cost-efficiently
- Assessing current suppliers cost-efficiently
- Supplier-related corrective action
- Minimum documentation for supplier qualification, assessment and corrective action
- Cost-efficient, compliant alternatives to common practices
LEARNING OBJECTIVES
- Explain QSR and ISO 13485 requirements for supplier selection and assessment
- Qualify new suppliers in a cost-efficient way
- Assess current suppliers efficiently
- Perform supplier-related corrective action
- Keep the minimum documentation needed for compliance
WHO WILL BENEFIT?
- Purchasing Management
- Regulatory Management
- QA Management
- Consultants
Supplier evaluation can absorb a large share of quality resources. This webinar helps regulated companies lower the cost of supplier evaluation and assessment without losing control or compliance.
It suits purchasing, regulatory and QA managers and consultants.
- QSR and ISO 13485 requirements for supplier selection and assessment
- Qualifying new suppliers cost-efficiently
- Assessing current suppliers cost-efficiently
- Supplier-related corrective action
- Minimum documentation for supplier qualification, assessment and corrective action
- Cost-efficient, compliant alternatives to common practices
- Explain QSR and ISO 13485 requirements for supplier selection and assessment
- Qualify new suppliers in a cost-efficient way
- Assess current suppliers efficiently
- Perform supplier-related corrective action
- Keep the minimum documentation needed for compliance
- Purchasing Management
- Regulatory Management
- QA Management
- Consultants
Speaker Profile
Jeff Kasoff
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 …
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