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Jeff Kasoff

Jeff Kasoff is Keynote Speaker at Compliance key Inc. Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.


 Webinar Id: LSHCHJK004
 6 months unlimited
 Duration 60 mins

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Al........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCEJK003
 6 months unlimited
 Duration 60 mins

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well a........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBJK002
 6 months unlimited
 Duration 60 mins

Best Practices in Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a Lean, Cost-effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.  Most medical device manufacturers have acceptable systems in place to assure component quality. B........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCBJK001
 6 months unlimited
 Duration 60 mins

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

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 in the corrective action, and Quali........

$167 Recorded (6 months unlimited access)


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