Corrections and Removals - Understanding and Implementing the Final Guidance Document 2015 covers topics such as:
- The guidance document and its intention and use
- The provisions of the regulations that relate to devices with problems
- The four exemptions for reporting
- The regulations for correction & removal
- How FDA will classify the report as a recall
- The need to keep records when a change is not reportable
- You obligations to manage the recall
Corrections and Removals - Understanding and Implementing the Final Guidance Document 2015 brings together attendees from:
- Quality Assurance
- Professionals from device companies involved in production changes, design changes, medical device reporting, and field actions:
- Legal Counsel
- Regulatory Affairs
- Medical Device Reporting Specialists
- Complaints Specialists
- Risk Management Specialists
- Field Change Specialists
