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 oversight of the document control 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

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR?

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Best Practices in Complaint Management

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. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

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The 510(k) Submission: Requirements, Contents, and Options

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.

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A Design Control Primer

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction.

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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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