2. Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. 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. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.

3. Written procedures for complaint handling will ensure that all complaints are reviewed in a timely and uniform manner. A complaint log or complaint file is required and should be updated whenever necessary. Basic information for the file includes but is not limited to the name of the device, date the complaint was received, complainant name and address, nature and details of the complaint, and the device identification/control number. When reviewing a complaint, be sure to determine whether any additional investigation is necessary. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications should be investigated further. Pay special attention to whether the complaint triggers any reporting requirements under FDA regulations. If the complaint triggers a Medical Device Report (MDR), ensure that the complaint file is clearly identified or maintained separately from other complaint files.

4. 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. Common FDA observations are inadequate procedures or not following procedures for receiving, reviewing, and evaluating complaints; failure to close out complaints in a timely manner; and a disconnect between complaints with adverse events and MDR requirements.

5. Areas Covered in the Session
Log the complaint at intake, investigate, deliver resolution, regulatory reporting and closeout
Understand how and why CAPA is tied in to product complaint investigations
Examples of tools currently being used to conduct investigations
Risk-based decision making and escalation rules and triggers associated with complaint handling
How far and in-depth do you go with your investigations and RCA (Root Cause Analysis)
Details do matter and data capture with analyses and 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
Trending of complaints, criteria and categories
Trending complaint data helps management detect patterns of failures and evaluate the effectiveness of CAPA and how it impacts effectiveness checks
How to improve and bullet-proof your product complaint management system with investigations

6. Who will benefit :
All levels of Management for all departments and those who desire a better understanding of complaint handling from intake or receipt, processing and investigation, trending and to close-out, including:
Complaint Handling Unit.
Complaint Analyst.
QA/QC/Compliance/Regulatory Affairs.
Marketing & Sales & Customer Service.
Quality Engineering.
Field Service.
Engineering/Technical Services.
Consultants.
Operations and Manufacturing.

7. Instructor Profile
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.

8. Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.

9. Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO registration and CE Mark; and multi-country product registrations and licensing.

10. Mr. Dills manages regulatory problems (e. g
Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

11. He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with regulatory authorities; executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Asia Pacific.
He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.