Live Webinar
on
Best Practices in Complaint Management
Date & Time: Wednesday, November 2, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Jeff Kasoff
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Areas Covered in the Session: l
FDA and ISO requirements for complaint handling
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Establishment of complaint handling program What constitutes a complaint ISO-specific implications of complaint handling The roles of investigation and corrective action in complaint handling Complaint trending and reporting Application of risk management to complaint handling program
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Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. ...more
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This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: l l l l l l
Regulatory Management QA Management Customer Service Personnel Sales Personnel Quality System Auditors Consultants
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