Device Complaint Handling: Implications for CAPA, Reporting, Recalls and More
Venue: Your Office
|Event Date/Time: Oct 05, 2010|
In this 90 minute audio conference, medical device expert Judith Andrews, Ph.D. will address the essential elements for maintaining an effective and compliant complaint handling system. Additionally, she will explain what you need to know about CAPA, reporting, and recalls when handling complaints.
***SAVE 10% on this Audio Conference When You Order By September 3rd! Just Enter Web Offer Code "100510-10" at Checkout.
Questions To Be Answered:
* What 3 factors should be used in deciding whether to investigate a complaint?
* What are the 9 sources of complaints and how should you respond to each?
* How can you best identify, investigate and close complaints?
* What 6 elements should be included in every complaint file?
* What are the 7 most common complaint failures and how can you prevent them from occurring?
* How will the increased FDA emphasis on enforcement impact your complaint handling?
Attendees Who Will Benefit From This Audio Conference Include:
ANYONE involved in receiving, reviewing or investigating complaints, including:
* Compliance officers
* Data management and statistics personnel
* Engineering and design controls teams
* Executive management
* Manufacturing directors and supervisors
* GMP/QSR auditors
* QA/QC personnel
* Regulatory/legislative affairs professionals
* Risk management specialists
* Training personnel
* Consultants/service providers