Streaming Course

Complaint Handling and Investigation: Linking CAPA, MDR Reporting, Trend Evaluation, and Recall Considerations

Course Information

Course Type: Streaming Course
Course ID: LSP1619
Format: Streaming
Duration: 90 Minutes
Presenter: Meredith L. Crabtree

Registration Options

Format: Streaming
Duration: 90 Minutes

Streaming (Per Attendee): USD 290.00

About the Course

Complaint handling programs often sit at the center of multiple quality and regulatory processes, yet many organizations continue to manage complaints, investigations, CAPA activities, MDR evaluations, trending programs, and recall decisions as largely separate functions. In practice, the most significant compliance risks frequently emerge not from the initial complaint itself, but from how information is interpreted, escalated, connected, and acted upon across the quality system. Questions often arise around investigation depth, reportability determinations, recurring complaint trends, CAPA initiation criteria, and when isolated events may indicate broader product or process concerns.

This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions. The discussion will explore investigation strategies, escalation pathways, trend evaluation, MDR decision-making, CAPA linkages, and recall considerations. Practical examples will be used to demonstrate how organizations can strengthen decision-making while maintaining consistent, defensible, and risk-based complaint management practices.

Key Areas Covered

Determining When a Complaint Requires Investigation Beyond Initial Assessment
Distinguishing Isolated Events from Emerging Product or Quality System Issues
Evaluating Complaint Trends Before They Become Larger Compliance Problems
Determining When Complaint Information Supports CAPA Initiation
Making Defensible MDR Reporting Decisions with Incomplete Information
Escalation Decisions That May Lead to Field Actions or Recall Evaluation
Documentation and Evidence Supporting Complaint Investigation Conclusions
Regulatory Expectations for Complaint Handling, Trending, CAPA, and Post-Market Decision-Making

Who Should Attend

Quality Assurance (QA)
Complaint Handling and Post-Market Surveillance Personnel
Regulatory Affairs
CAPA and Quality Systems Professionals
Medical Device and Pharmaceutical Quality Professionals
Risk Management Teams
Compliance and Audit Personnel
Quality and Regulatory Leadership

Presenter

Meredith L. Crabtree

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, MDR, Complaint Handling and Recall support. She also performs regulatory assessments and Quality trainings.