Compliance4All, Online
2017-01-18
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.
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:
Regulatory Management Quality Assurance Professionals Consultants
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