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Subscribe NewsletterRecalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
Product Id
:
600065
Overview: 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.
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.
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
- CMD-specific requirements (Canadian device regulations)
Who Will Benefit:
- Regulatory Management
- Quality Assurance Professionals
- Consultants
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors