ComplianceOnline

Complaint Management: Best Practices to Assure Compliance and Customer Retention

Instructor: Jeff Kasoff
Product ID: 700986
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2017

Training CD / USB Drive

$299.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to 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 will discuss best way to document customer feedback, what constitutes a complaint, and what to do with non-complaint feedback. The session will also highlight 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
  • How to Handle “non-complaints”
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program
  • Benefits/Detriments of a Reply to the Customer

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:

  • Customer Service (your “complaint taker”)
  • Regulatory personnel
  • Quality Engineering personnel
  • Sales and Marketing personnel
  • Customer Service personnel
  • R&D personnel
  • Manufacturing Engineering
  • Executive Management
  • Consultants
  • Quality system auditors
Instructor Profile:
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff 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. He received his Regulatory Affairs Certification in 1996.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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