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 …
Dealing With Difficult People In Life & Work
How to Write Effective Audit Observations: The Principles f…
How to Document Employee Discussions and Why it is Important
OSHA Requirements for Supervisors, Project Leaders & HR - W…
FDA Compliance And Laboratory Computer System Validation
4-Hour Virtual Seminar on Transformational Leadership - The…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Negotiating Skills For Professional Results - Winning Strat…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Building Thriving Teams: Proactive Strategies for Managers …
Designing Employee Experiences to Build a Culture of Compli…
President Trumps Executive Orders And What They Mean to Emp…
Empowering Conflict Resolution: Letting Go to Gain Control
The Anti-Kickback Statute: 2025 - Year in Review
Navigating Alcohol and Drug Addiction Protections Under the…
50+ new Excel features so far this decade
FDA Technology Modernization Action Plan (TMAP) and Impact …
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
Workplace Investigations 101: How to Conduct your Investiga…
From Challenges to Compliance: Understanding Dietary Supple…
FDA Regulation of Artificial Intelligence/ Machine Learning
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
The Importance of the first 5 seconds when presenting
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Why EBITDA Doesn't Spell Cash Flow and What Does
Understanding the incredible uses and fallbacks of ChatGPT
Mastering Performance Management: Strategies for Continuous…
The Monte Carlo Simulations in Excel for Risky Investments
Impact Assessments For Supplier Change Notices
Navigating FDA Regulations – A guide for medical device and…
California Meal and Rest Breaks: What You Don't Know Can Co…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Onboarding is NOT Orientation - How to Improve the New Empl…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
6-Hour Virtual Seminar on Learning the Highlights of Excel …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
2025 Top Employment Regulations That Will Impact Employers!
Building GMP Excellence: A Guide to Implementing Compliant …