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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 certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE. 


Live Webinars

Chronicles

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By: Jeff Kasoff

Recorded Session

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 compan…

Industry: Medical Devices   Duration: 60 Minutes  

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By: Jeff Kasoff

Recorded Session

The FDA Inspection: Preparation, Performance and Follow-Up

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rati…

Industry: FDA Compliance   Duration: 75 Minutes  

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By: Jeff Kasoff

Recorded Session

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the …

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Jeff Kasoff

Recorded Session

Supplier Management: Overcoming Challenges and Exploring Opportunities

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must m…

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Jeff Kasoff

Recorded Session

Navigating FDA Inspections: From SOP to 483

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rati…

Industry: FDA Compliance   Duration: 60 Minutes