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! 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.
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.
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.
Jeff Kasoff
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Strategies For Job Seekers: Best Practices For A Strategic …
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
Retention Starts Here: Stop Losing Your Critical Talent and…
AI and Human Resources: The Great Opportunity!
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI and Change Management - How to Lead with Confidence and …
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
Employee Handbooks: 2025 Critical Issues
Excel Power Skills: Master Functions, Formulas, and Macros …
The Courage to Speak: Overcoming Fear and Owning the Room
6-Hour Virtual Seminar on Learning the Highlights of Excel …
6-Hour Virtual Boot Camp on Microsoft Power BI
Finance & Accounting 101 Simplified
Compliance Under Fire: Navigating I9 Immigration Raids & …
Developing an Agile Workforce with Emotional Intelligence (…
Empowering Conflict Resolution: Letting Go to Gain Control
FDA Regulation of Artificial Intelligence/ Machine Learning
Human Error Reduction Techniques for Floor Supervisors
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Leadership: Strategic Planning and Decision Making
Secrets Of Psychology - Why People Do The Things They Do
How To Conduct An Internal Harassment And Bullying Investig…
FDA Compliance And Laboratory Computer System Validation
Marketing to Medicare or Medicaid Beneficiaries - What You …
Polish your Presence on Linkedin - The Powerful Profile
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Leveraging Artificial Intelligence in HR
Harassment, Bullying, Gossip, Confrontational and Disruptiv…