Jeff Kasoff

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.

Jeff Kasoff

The FDA Inspection Process: From SOP to 483

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Jeff Kasoff

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.

Jeff Kasoff

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.

Jeff Kasoff

ISO 13485 for Medical Device QMS

This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.

Jeff Kasoff

The FDA Inspection Process: From SOP to 483

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

Jeff Kasoff

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.

Jeff Kasoff

How to Prepare for, Manage, and Follow-up to an FDA Inspection

<ul> <li>Does the FDA call in advance or just show up at my door? <br /> </li> <li>Where do I let the inspector go? <br /> </li> <li>Do I give them a tour? <br /> </li> <li>What should I let them see? <br /> </li> <li>Who should I let them talk to? Are they ever going to leave?</li> </ul>

Jeff Kasoff

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.

Jeff Kasoff

The FDA Inspection Process: From SOP to 483

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? 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!

Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulation

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.

Jeff Kasoff

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?

Jeff Kasoff

FDA Inspections - Do's and Don'ts

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 FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Jeff Kasoff

Purchasing and Supplier Controls in the Medical Device Industry

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.

Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulations

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.

Jeff Kasoff

DHF, DMR, DHR and TF - Regulatory Documents Explained

The FDA QSR and the Medical Device Directive specify certain records that should be included in your organization's quality system - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical File (TF).

Jeff Kasoff

FDA Inspections - Do's and Don'ts

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 FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Jeff Kasoff

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?

Jeff Kasoff

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.

Jeff Kasoff

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.

Jeff Kasoff

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.

Jeff Kasoff

Supplier and Internal Auditing

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

Jeff Kasoff

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.

Jeff Kasoff

Design Control for Medical Devices

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.

Jeff Kasoff

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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GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

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