Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements

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.

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Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements

Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements

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Instructor : Jeff Kasoff

Product Id : 600065

Overview: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.

It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices.

Areas Covered in the Session:

Regulatory definitions of recalls, removals, and market corrections
Instances which require recalls, removals, or market corrections
What to do during recalls, removals, and market corrections
Recordkeeping requirements for recalls, removals, and market corrections
ISO 13485-specific requirements
CMD-specific requirements (Canadian device regulations)

Who Will Benefit:

Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
Quality System Auditors

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

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