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Product Complaints: Complaint Handling from Intake to Closure

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.

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Product Complaints: Complaint Handling from Intake to Closure

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  1. Product Complaints: Complaint Handling from Intake to Closure Speaker: David R. Dills| Date: 27th September2016 2016 2016 | 10:00 AM PST | 01:00 PM EST Contact Us : Email: support@grcts.com | Tel: +1-248-233-2049

  2. 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. Description:

  3. 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 Areas Covered in the Session:

  4. Regulatory Affairs • Clinical Affairs • Quality Assurance/Quality Control • Compliance • Marketing & Sales • Manufacturing and Technical Services • Engineering • IT/MIS • Executive Management Who will benefit:

  5. 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.   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 is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups. Instructor Profile :

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