Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

• Understand how and why CAPA is tied in to product complaint investigations
• Examples of tools currently being used to conduct investigations
• How far and in-depth do you go with your investigations
• What are current FDA "hot" buttons and trends
• Benchmarks and best practices for investigations
• How to become a "good" investigator and the emphasis on closed-loop investigations
• Why risk-based approaches are vital to the decision-making process
• How to improve and bullet-proof your product complaint management system with investigations

• 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.