Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements Course "Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements" has been preapproved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Date & Time:
Thursday, August 02, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Jeff Kasoff
Price : $245.00
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
(for one participant)
Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. 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.
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. ...more
Why should you attend: There are certain circumstances in which a report from the field Suggest a Topic More Webinars requires the device manufacturer to take steps regarding product in Your Necessity is our Priority the field. It is critical that the company take the required steps in the required timeframes. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship product.
Areas Covered in the Session: l
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)
Click here to register for this webinar Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include: l
Quality Assurance Professionals Consultants Sales/Marketing Management
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Senior and mid-level Management Quality System Auditors
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards,
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Published on Aug 1, 2012
Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There a...