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.
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.
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.
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
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
- Operations and Manufacturing
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.
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.
For More Details: Compliance Online Training.
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