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Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

 
  August 10, 2016  
     
 
ComplianceOnline, United States
2016-08-31


This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

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 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 Webinar:

  • 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

 

 
 
Organized by: ComplianceOnline
Invited Speakers:

Instructor Profile:

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 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.

 
Deadline for Abstracts: 2016-08-30
 
Registration:
Phone No: +1-888-717-2436
Email Id: referral@complianceonline.com
E-mail: referral@complianceonline.com
 
   
 
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