Conducting Successful Product Complaint Investigations

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. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

Areas Covered in the seminar:

• 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.

Who will benefit:

This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. The employees who will benefit include:

• 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

Instructor Profile:
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Mr. Dills’ academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

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