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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.


 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.

 Upcoming Webinars
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?
Live  Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$199.00

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. Your goal is to get the 510(k) through the review process as quickly as possible.
Live  Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00

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).
Live  Thursday, July 11, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00

Process Validation Principles and Protocols for Medical Devices
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.
Live  Thursday, July 25, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00

...more
 Recorded Webinars
Development and Audit of Complaint Handling and MDR Processes
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.
Recorded  Thursday, May 6, 2010 10:00 AM PST | 01:00 PM EST,  Duration:60 Minutes
$295.00

Equipment Validation, Tracking, Calibration, and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
Recorded  Tuesday, April 13, 2010 10:00 AM PST | 01:00 PM EST,  Duration:60 Minutes
$295.00

ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
Recorded  Thursday, March 25, 2010 10:00 AM PST | 01:00 PM EST,  Duration:60 Minutes
$295.00

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
Virtually all field inspections performed by FDA inspectors are done according to the QSIT.
Recorded  Thursday, March 11, 2010 10:00 AM PST | 01:00 PM EST,  Duration:60 Minutes
$295.00

...more


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