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.
WHY SHOULD YOU ATTEND?
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.
LEARNING OBJECTIVES
- 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?
- 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
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.
- 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
- 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 Profile
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 …
Upcoming Webinars
From Challenges to Compliance: Understanding Dietary Supple…
How To Conduct An Internal Harassment And Bullying Investig…
Improving Employee Engagement & Retention Through Stay Inte…
Using Behavior Based Interviewing for Finding the Best Matc…
Leadership: Strategic Planning and Decision Making
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Documenting Employee Behaviour, Performa…
De-Stressing Your Leadership for Greater Impact
Emotional Intelligence: Mastering the Emotions of Great Lea…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
How to Conduct Exit Interviews - Implementing and Enhancing…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Finance & Accounting 101 Simplified
Understanding How To Write A Compliant CAPAs
Mastering the Candidate Experience in Talent Acquisition.
4-Hour Virtual Seminar on Transformational Leadership - The…
Uplifting the Credibility of HR: How to Build the Credibili…
Treasury Risk Management, Funding, Liquidity, Interest Rate…
Courts No Longer Have to Give Deference to Agency’s “Expert…
21 CFR Part 820 - Quality System Regulation - Applying Prin…
Building Fair Chance Hiring Policies in 2024
HIPAA Bootcamp for Health Care Providers, Professionals, an…
Building GMP Excellence: A Guide to Implementing Compliant …
FDA Technology Modernization Action Plan (TMAP) and Impact …
Weathering the Storm: Navigating Resource Constrained Waters
How to Survive an Emotionally Toxic Workplace
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Excel Power Skills: Master Functions, Formulas, and Macros …
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Understanding the Artificial Intelligence Landscape
Employee Handbook Requirements for 2024. Includes Updated F…
Essential Job Functions According to the American with Disa…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
FDA Audit Best Practices - Do's and Don'ts
Engineering Change Management (ECM)
Batch Record Review and Product Release
Workplace Investigations 101: How to Conduct your Investiga…