Market Corrections in Compliance with FDA Conference
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
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501094LIVE?channel=mailer&camp=Webinar&AdGroup=govevents_Jan_2017_SEO
Twitter Follow us – https://twitter.com/compliance4all
Facebook Like us – https://www.facebook.com/Compliance4all
LinkedIn Like us – https://www.linkedin.com/company/compliance4all
Speaker and Presenter Information
Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc
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.
Relevant Government Agencies
Market Corrections
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Wed, Jan 18, 2017, 10:00am - 11:00am
PT
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
Join the event conversation:
@Compliance4all
#Compliance4all