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Speaker Profile
JEFF KASOFF

Jeff Kasoff, RAC, CMQ/OE, LBB, 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 the 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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Showing 1 to 6 of 6 (1 Pages)
$200.00
The FDA Inspection: Best Practices for Preparation, Behavior, and Response

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
The FDA Inspection: Best Practices for Preparation, Behavior, and Response

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPreparation&..

$200.00
Best Practice for Complaint Handling to Assure Customer Retention

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
 Download Catalog
Best Practice for Complaint Handling to Assure 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 customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..

$200.00
Best Practices for a Compliant, Lean Supplier Management Program

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
 Download Catalog
Best Practices for a Compliant, Lean Supplier Management Program

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 make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that yo..

$200.00
Complaint Management: Best Practices to Assure Compliance and Customer Retention

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
 Download Catalog
Complaint Management: Best Practices to Assure 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 customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..

$200.00
Equipment Validation, Tracking, Calibration and Preventive Maintenance

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
 Download Catalog
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. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product ..

$200.00
The FDA Inspection: Preparation, Performance and Follow-Up

 Jeff Kasoff
 Recorded Webinar
 60 Minutes
 Download Catalog
The FDA Inspection: Preparation, Performance and Follow-Up

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discu..

Showing 1 to 6 of 6 (1 Pages)