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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:

 

 

Register Now

Instructor Profile:

Thursday, August 02, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Jeff Kasoff

Location: Online

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

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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

Regulatory Management

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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,


Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

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

Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There a...

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