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EVENT DATE
Aug 2017
M T W T F S S
010203040506
EXPO DATE
Aug 2017
M T W T F S S
010203040506

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Online Event
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Type: Online Event

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Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

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EVENT DESCRIPTION

This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Objectives of the Presentation

  • Understand what FDA and ISO complaints are
  • What are the FDA and ISO requirements for complaints
  • What are the documentation requirements
  • What are the reporting requirements
  • Requirements for a complaint system

Why Should you Attend
Many complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as "isolated occurrence" and "low risk." Further, from a business perspective, how do you let your customers know that you received their complaint, when you know that their next question may be the dreaded "What did you find out?" A compliant quality system has one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address these issues and more.

Further, unlike many complaint management trainings, this session's streamlined review of the regulations enables detailed focus on recommended contents of complaint records and root cause investigations. Methods for trending of complaints are included, as well as form on which to document risk.

Areas Covered

  • 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
  • Customer reply: benefits, detriments, and recommended practices

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 (i.e., 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.

For Registration

https://www.onlinecompliancepanel.com/webinar/COMPLAINT-MANAGEMENT-502650/AUGUST-2017-ES-EVENTSINAMERCIA

Note: Use Promo code SAQR4 and get 10% off on registration (Valid till AUGUST 31st 2017)

Not sure if you want to exhibit at or attend the Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations? See the panels below to get the information you need to make an informed decision.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Education Events
Other Industries:
Business, Education Events, Management/Leadership
Audience:
This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. Register for the interactive webinar today.
Notes:
Customer complaints, handling customer complaints, customer feedback management, customer complaint FDA regulations, FDA compliance training , ISO standards training, customer complaint documentation, customer complaint regulatory requirements, quality system regulations, medical device training, customer complaint management system, managing customer complaints, complaint management solutions, fda quality system, complaint handling system, customer complaint management process, ISO medical device standards, fda quality system regulation, ISO 13485 regulations.
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