Device Complaint Handling: Implications for CAPA, Reporting, Recalls and More

Venue: Your Office

Location: Your City, United States

Event Date/Time: Oct 05, 2010
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Description

Over half the Warning Letters issued for quality system violations in the past six months have included issues related to complaint handling and CAPA. The FDA has increased its focus on enforcement, and compliance with 820.198 of the Quality System Regulation will be scrutinized now more than ever.

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

Venue

Additional Information

ONLINE Audio Conference, CD and Transcript ($479.00) Recommended! Audio Conference plus On-Demand ($400.00) Audio Conference only ($325.00) CD and Transcript ($400.00) On-Demand ($325.00)