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  • Complaint Handling in Compliance with FDA and ISO

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Sep 12, 2013 10:00 AM
  • End Time:
  • Thursday - Sep 12, 2013 11:00 AM
  • Location:
  • Online
  • This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program.

    Why You Should 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. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.
    This complaint handling webinar 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.

    Areas Covered in the Seminar:
    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
    Quality System Auditors

    Instructor Profile:
    Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. 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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