Speaker Profile

Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc

Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.

Speakers

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

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 all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

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Supplier and Internal Auditing

The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.

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Personnel Training to Assure QSR and ISO Compliance

This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

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