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
Why Should you Attend
- 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
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.
Who will Benefit
- 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
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
- Quality system auditors