Overview: 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 Session:FDA's Complaint Definition 820.3 (b)Complaint DocumentationPart 803 - Medical Device ReportingPart 806 - Reports of Corrections & RemovalsWarning letters and other FDA RemediesComplaint Handling PitfallsWho Will Benefit: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Some employees who wish to gain a better understanding include:Quality & Regulatory ProfessionalsManufacturing & Design EngineersMarketing Product ManagersJohn Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking.GlobalCompliancePanel Phone: 800-447-9407Fax: 302-288-6884