subject: Raps Pre-approved Webinar On recalls & Vigilance when To Report Complaints -globalcomplianc [print this page] Description:Complaint handling is one of the core aspects of medical device business, as improper or inadequate complaint handling can result in regulatory action from the FDA. This is because the FDA has very clearly spelt out, crystal clear rules on complaint handling, which many device manufacturers ignore at their own peril. The result can be costly recalls or warning letters.
To add insult to the injury, the FDA announces these recalls and other actions on its website and trade publications, making its actions known to everyone who matters in the industry. This can not only tell the firms competitors that the FDA initiated such an action; it can also cause the firms stocks to nosedive.
This webinar will let firms know some of the common stumbling blocks that they can avoid during complaint handling. It offers suggestions to firms on how to disentangle complicated jargon and make sense of regulations by bringing them down to the level of the layman.
John Chapman, BS, MBA, RAC has been in the medical device regulatory industry for over 30 years, over 10 of which have been spent with the European Union's medical device directive, 93/42/EEC. Leading two device companies to ISO quality system certification and CE marking is one of the highpoints of his highly successful career.
In the course of performing regulatory due diligence on over a dozen acquisitions in the past 12 years, John has been exposed to numerous Quality Systems, including consent decrees. This work has also acquainted him with many notified bodies.
He earned his Regulatory Affairs Certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
