This session will include the requirements for all of the complaint handling 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.
Why You Should Attend:
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! In this webinar, learn the best practices for managing complaints.
Why You Should Attend:
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! In this webinar, learn the best practices for managing complaints.
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
Speaker
Jeff KasoffCourse Provider
Jeff Kasoff,
