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.
Why should you attend:
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. 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:
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
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:
Quality Assurance Professionals
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.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501094LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
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