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Jeff Kasoff

Principal Consultant, Lean to Quality, LLC

Jeff Kasoff , RAC, CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.



  •  Friday, January 25, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Complaint Handling in Compliance with FDA and ISO Regulations

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.

  •  Friday, February 8, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures.

  •  Friday, February 22, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Equipment Validation, Tracking, Calibration and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.

  •  Friday, March 8, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
The FDA Inspection: Preparation, Management, 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.





  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Complaint Handling in Compliance with FDA and ISO Regulations

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Equipment Validation, Tracking, Calibration and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.