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GlobalCompliancePanel, USA
2010-11-18
This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.
Why Should You Attend: 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: - FDA and ISO requirements for complaint handling
- 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
Who Will Benefit: 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: - Regulatory management
- QA management
- Customer Service personnel
- Sales personnel
- Consultants
- Quality system auditors
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Jeff Kasoff: - Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff has presented dozens of webinars in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
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Deadline for Abstracts:
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2010-12-09
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Registration:
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Thursday, November 18, 2010
10:00 AM PDT | 01:00 PM EDT | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
| | | Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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