Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations.

This complaint management webinar will include the requirements for defining, documenting, and implementing a customer complaint handling system, including the customer complaints procedure for complaint review, investigation, and corrective action, as well as the ISO-specific implications.

This webinar will discuss the best way to document customer feedback management, what constitutes a customer service 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 handling customer complaint system will be reviewed, and a specific risk management system explained.

Why Should You Attend

This webinar contains a streamlined review of the regulations, allowing the clear majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations.

The speaker will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant.

Among these recommendations are contents of complaint records, root cause investigations, and corrective actions.

Equally critical to compliance is communication; this webinar reviews the appropriate types of complaint data to include depending upon your audience and/or the type of meeting – it’s critical to understand what executive management wants to see vs. what your weekly/monthly Compliant Committee needs to see.

This webinar also covers the application of risk management principles to complaint investigation.

Areas Covered In This Webinar

Most 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, as one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address these issues and more.

Learning Objectives

• FDA and ISO auditor training requirements for complaint handling
• Establishment of complaint handling program
• What constitutes a complaint
• 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

• Regulatory Management Personnel
• QA Management Professionals
• Customer Service Personnel
• Sales Personnel
• Consultants
• Quality System Regulations Auditors