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.

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 13485 registration and
CE Mark; and multi-country product registrations and licensing.

10. 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.