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Mr.Jeff Kasoff
Area Of Expertise : FDA Compliance
30 Years Of Experience
Training Industry : Life Sciences
Jeff Kasoff, RAC, CMQ/OE 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 in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.
4 results Found
Recorded Webinar
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 w ...
- Basic & Intermediate & Advanced
- 60 Mins
Recorded Webinar
Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements
This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance.
- Basic & Intermediate & Advanced
- 60 Mins
On-Demand Webinar
Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation and corrective action, as well as the ISO-specific implications. Also, discussed will be ...
- Intermediate
- 60 Mins
Recorded Webinar
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 rationale, strategies and flows on how to plan for an inspection, the inspe ...
- Intermediate
- 60 Mins