Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result.
This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.
Areas Covered in the Session:
* Complaints Definitions; FDA, EU & Canada
* How to Document Complaints & Adverse Events
* US & Foreign Regulatory Reporting
* Recall, Vigilance, Correction & Removals
* Enforcement Actions
Who Will Benefit:
* Regulatory Professionals
* Quality Engineers
* Manufacturing Engineers
* Operations Executives
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.
Areas Covered in the Session:
* Complaints Definitions; FDA, EU & Canada
* How to Document Complaints & Adverse Events
* US & Foreign Regulatory Reporting
* Recall, Vigilance, Correction & Removals
* Enforcement Actions
Who Will Benefit:
* Regulatory Professionals
* Quality Engineers
* Manufacturing Engineers
* Operations Executives
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
