Complaint Handling and Management: From Receipt to Trending

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.

• 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

• 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

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.

• 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

David Dills is currently a Global Regulatory Affairs Consultant after departing his last company earlier this year in 2024 and a full-service CRO as Director of Regulatory Services. He is a seasoned Global Regulatory Affairs, Regulatory Strategist, and Compliance professional with demonstrated capabilities and a track record with more than 35 years of accrued experience in the functional areas of Regulatory Affairs, Regulatory Intelligence, Regulatory Compliance, Global Regulatory PM/PD, and QA/QAE for US and international developers/manufacturers/sponsors for early-stage, mid- and large-size enterprises for pharma, biologics, combination, and medical device products from investigational to marketing approval. He has worked for CROs, consultancies, and manufacturers in different roles and capacities. A key focus is regulatory strategy and bringing products from new product development from pre-clinical to global market transfer and commercial release and collaborating with the regulatory authorities and agencies. With his depth and breadth of regulatory and compliance experience, he examines all aspects of regulatory and compliance, to help companies uncover potential strategic regulatory risks while cultivating novel, targeted strategies to help companies achieve regulatory approval in multiple markets. This is to ensure that regulation provides consistent strategic messaging and cohesion throughout the entire regulatory and compliance lifecycle for the key stakeholders of the organization. He manages regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities. He enjoys developing and executing comprehensive regulatory strategies for companies, considering their specific business objectives regulatory requirements, and commercial considerations in global markets, and supporting sound regulatory submissions, interactions, and outcomes with regulatory authorities. This includes leading the interactions with Health Authorities on behalf of companies in formal meeting settings, including providing pre-meeting coaching and preparation of briefing documents, negotiations, and post-filing support. He enjoys providing regulatory leadership experience with a broad spectrum of indications, therapeutic areas, and product modalities at multiple phases. He has academic degrees in Biology and Environmental Science and is an active member in various professional industry groups and affiliations.