Medical Device Complaints, MDR’s and Recalls

Date: October 24 2011

Location: Palo Alto, California, USA

Website: http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=700196?channel=boxes&arrow

About This Event

Why Should You Attend:
All Medical Device firms need to be aware of the benefits of compliance, as well as the dangers of inadequate complaint handling.

Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters.

FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Areas Covered in the Seminar:

- FDA's Complaint Definition 820.3 (b)
- Complaint Documentation
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections & Removals
- Warning letters and other FDA Remedies
- Complaint Handling Pitfalls

NOTE : Use this Promocode (128600)to avail 10% discount,Valid till December 30 & add another webinar to your shopping cart and get 20% off on its price.

Sign Up!

http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=700196?channel=boxes&arrow

Tags

and, complaints, compliance, complianceonline, device, mdr, medical, online, recalls, s, seminar, training, webinar