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 …
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Is Your Culture Working For or Against Your Success? If You…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Human Element of Leadership in the Hybrid Work Experien…
Transform Data into Insights: A Beginners Guide to Excel Pi…
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
How to Navigate Political Speech in the Workplace
Project Management for administrative professionals
How to Prepare For and Host a FDA Inspection and Respond to…
Mastering Year-End Payroll and Tax Compliance for 2024
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Eliminate Harmful And Unproductive Drama In The Workplace
FDA Technology Modernization Action Plan (TMAP) and Impact …
The Anti-Kickback Statute: Enforcement and Recent Updates
5 Key Components of Good Manufacturing Practices to obtain …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
Managing Toxic & Other Employees Who Have Attitude Issues
Successful Strategies for FDA Expedited Pathways for Your D…
Protect Your Company With The End of the Year HR Checklist
The Power Of Trust In The Workplace- Improving Your Career …
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Construction Lending And Real Credit Administration: Evalua…
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
