This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law.
Areas Covered in the Session:
Create and use a recall operational procedure and what should it contain
Understand what are effectiveness checks
What happens in a medical device recall
Learn why a recall is either a correction or a removal depending on where the action takes place.
Understand why is required for the recall strategy as expected by FDA
Medical device recall authority and guidance
Depth of recall and using a viable, sustainable and effective strategy
Understand why the documentation and paper trail are so critical and termination of a recall
Who will benefit:
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. The employees
who will benefit include:
All levels of Management for all departments and those who desire a better understanding
Marketing & Sales
Operations and Manufacturing
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500838LIVE?channel=mailer&camp=webinar&AdGroup=eventsinamerica_Nov_2016_SEO
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