A working complaint handling system is a core part of any quality system. Every complaint about a product has to be evaluated and, where needed, investigated and analyzed, with corrective action taken. This 90-minute complaint handling and management webinar follows that process from receipt to trending.
You'll see how CAPA connects to complaint investigations, which tools teams use to investigate, how deep an investigation should go and why risk-based thinking matters for each decision. The session highlights regulatory expectations for both pharmaceuticals and medical devices, current FDA focus areas, and benchmarks for timely, closed-loop investigations.
WHY SHOULD YOU ATTEND?
Complaints are a strong signal of problems with how a product is used, designed or made, and they cannot be ignored. One well-investigated complaint can prompt corrective action, while trends across many complaints can drive changes to a product, its labeling, packaging or distribution.
This session helps QA, QC, compliance, regulatory, engineering, operations, sales, customer service staff, managers and consultants decide whether a complaint is valid, find the root cause and prevent repeats.
AREA COVERED
- How and why CAPA is tied to product complaint investigations
- Tools currently used to conduct investigations
- How far and how deep to take an investigation
- Current FDA hot buttons and trends
- Benchmarks and best practices for investigations
- Becoming a good investigator and the focus on closed-loop investigations
- Why risk-based approaches are vital to decision-making
- Strengthening your product complaint management system through investigations
LEARNING OBJECTIVES
- Explain how CAPA links to product complaint investigations
- Choose suitable tools for complaint investigations
- Decide how far and how deep an investigation needs to go
- Recognize current FDA hot buttons and trends
- Apply risk-based approaches to complaint decisions
- Run closed-loop investigations using benchmarks and best practices
- Strengthen your complaint management system
WHO WILL BENEFIT?
- All levels of Management for all departments and those who desire a better understanding
- QA/QC/Compliance/Regulatory Affairs
- Marketing & Sales & Customer Service
- Engineering/Technical Services
- Consultants
- Operations and Manufacturing
Complaints are a strong signal of problems with how a product is used, designed or made, and they cannot be ignored. One well-investigated complaint can prompt corrective action, while trends across many complaints can drive changes to a product, its labeling, packaging or distribution.
This session helps QA, QC, compliance, regulatory, engineering, operations, sales, customer service staff, managers and consultants decide whether a complaint is valid, find the root cause and prevent repeats.
- How and why CAPA is tied to product complaint investigations
- Tools currently used to conduct investigations
- How far and how deep to take an investigation
- Current FDA hot buttons and trends
- Benchmarks and best practices for investigations
- Becoming a good investigator and the focus on closed-loop investigations
- Why risk-based approaches are vital to decision-making
- Strengthening your product complaint management system through investigations
- Explain how CAPA links to product complaint investigations
- Choose suitable tools for complaint investigations
- Decide how far and how deep an investigation needs to go
- Recognize current FDA hot buttons and trends
- Apply risk-based approaches to complaint decisions
- Run closed-loop investigations using benchmarks and best practices
- Strengthen your complaint management system
- All levels of Management for all departments and those who desire a better understanding
- QA/QC/Compliance/Regulatory Affairs
- Marketing & Sales & Customer Service
- Engineering/Technical Services
- Consultants
- Operations and Manufacturing
