Market Corrections in Compliance with FDA webinar by Compliance4all
- Start Date:
- Wednesday, 18 January, 2017
- End Date:
- Wednesday, 18 January, 2017 11:00am
- Health & Nutrition
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 ConsultantsSpeaker Profile: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.
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216