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
By: Jeff Kasoff
Dec. 18, 2025
Navigating FDA Inspections: From SOP to 483
An FDA inspection puts regulatory and quality teams in the spotlight, and the outcome depends on planning, training and composure. This 60-minute FDA inspection readiness webinar gives medical dev…
Industry: FDA Compliance Duration: 60 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
Chronicles
By: Jeff Kasoff
Recorded Session
Best Practices in Complaint Management for Regulatory Compliance and Customer Retention
Complaint management is one of the most cross-functional parts of a quality system. Customer service may take the complaint, sales and marketing may contact the customer for details, regulatory af…
Industry: FDA Compliance Duration: 60 Minutes
By: Jeff Kasoff
Recorded Session
Supplier Management: Overcoming Challenges and Exploring Opportunities
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 manage…
Industry: FDA Compliance Duration: 60 Minutes
By: Jeff Kasoff
Recorded Session
The FDA Inspection: Preparation, Performance and Follow-Up
An FDA inspection puts the people responsible for compliance in the spotlight. This 75-minute FDA inspection training gives medical device and pharmaceutical professionals the rationale, strategie…
Industry: FDA Compliance Duration: 75 Minutes
By: Jeff Kasoff
Recorded Session
Best practices for purchasing and supplier controls in the medical device industry
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 c…
Industry: Medical Devices Duration: 60 Minutes