BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T161823Z UID:47851e7c-fd8f-4df8-a347-68438d158f2e DTSTART:20210330T083000 DTEND:20210331T083000 CLASS:PRIVATE DESCRIPTION:
An effective complaint
handling system is an extremely important part of any quality system. Man
ufacturers should understand that any complaint received on a product shal
l be evaluated and\, if necessary\, thoroughly investigated and analyzed\,
and corrective action shall be taken. \;
\nThe results of this e
valuation should lead to a conclusion regarding whether the complaint was
valid\, what the root cause of the complaint was\, and what action is nece
ssary to prevent further occurrences. Complaints cannot be ignored. They a
re an excellent indicator of problems with the use\, design\, and/or manuf
acture of a product. A single complaint that is thoroughly investigated ma
y lead a company to take remedial or corrective action. It may also take a
n ongoing analysis of numerous complaints before a trend is spotted that c
auses a company to initiate changes in their product\, labeling\, packagin
g or distribution. The regulatory expectations for both pharmaceuticals an
d medical devices will be emphasized as well as overview of best practices
for timely and effective investigations. Trending is the only way a compa
ny can stay on top of emerging quality issues and address those that are m
ost pressing.
 \;
\n\n&bull\; Understand that although FDA does not
specify a standard complaint handling system\, the requirements do specif
y certain actions that shall be included in any system
\n&bull\; Gras
p and comprehend the definitions and elements of the regulatory requiremen
ts for Complaint Handling\, Medical Device Reporting and handling of Recal
ls
\n&bull\; All personnel who deal with customers\, or who may recei
ve a complaint call\, must be trained in the proper routing/handling of co
mplaints
\n&bull\; Provide information about FDA&rsquo\;s Medical Dev
ice Reporting (MDR) regulation and the Voluntary Reporting program called
MedWatch
\n&bull\; Introduce you Medical Device Reporting and to help
you better understand the process and benefits of Voluntary Reporting and
responsibilities \;
\n&bull\; Latest Amendments to the MDR Regul
ation to Implement FDAMA Changes
\n&bull\; To Recall or Not to Recall
: Issues to consider regarding whether a Field Action is required
\n&
bull\; Determine when a recall is required and how to manage a recall\, wh
o must report\, when to report\, what to report\, where to report\, record
keeping requirements\, FDA regulatory authority\, references and guidance<
br />\n&bull\; Seminar attendees are encouraged to bring examples of their
work from the functional area on the various topics as applicable for gro
up discussion
\n&bull\; Review and discuss pain points\, challenges a
nd solutions
 \;
\n\n&bull\; Reporting complaints
\n&bull\; Complaint evaluation and
investigation and effective root cause analysis
\n&bull\; Data colle
ction and trending
\n&bull\; CAPA process for investigating complaint
s
\n&bull\; Accelerate complaints recording\, investigation\, reporti
ng\, escalation/triggers and closure cycle as cases are automatically rout
ed from one stage to the next
\n&bull\; Gain enterprise-wide visibili
ty into the complaints data and track the process with performance metrics
\, dashboards or other indicators
\n&bull\; Improve communication and
teamwork on complaints across departments and functional areas
\n&bu
ll\; Drive continuous improvement by tying corrective actions with complai
nts for a closed loop quality process
\n&bull\; Improve management of
the complaint lifecycle with real-time trending and escalation of custome
r complaints
\n&bull\; Understand the History of MDR Regulation
\n&bull\; What types of Reports does the FDA receive and who must submit M
andatory Reports to the FDA?
\n&bull\; Who can submit Voluntary Repor
ts to the FDA? \;
\n&bull\; How to submit e-MDR reports and ensur
e timely reporting requirements are met for MedWatch 3500A
\n&bull\;
How Does the FDA Use Medical Device Reports?
\n&bull\; What are the e
xemptions\, variances\, or alternative forms of adverse event reporting re
quirements?
\n&bull\; Basics of a Recall: Initiation\, Classification
and Public Warning
\n&bull\; Medical Device Recall Reporting and Cla
ssification Levels
\n&bull\; Recall Responsibilities &\; Requireme
nts
\n&bull\; FDA&rsquo\;s Role
\n&bull\; Introduction to Medica
l Device Recalls: Industry Responsibilities
\n&bull\; Recall Communic
ation and Strategy
\n&bull\; Monitoring and Auditing Recall Effective
ness \;
\n&bull\; Recall Termination
\n&bull\; Guidance for
Industry\, Trends and FDA Inspection &\; Enforcement Statistics and Tre
nd
This seminar wi ll provide an overview and in-depth snapshot of the process for managing y our product complaint/complaint handling program\, Medical Device Reportin g program and addressing and facilitating Recalls. Employees who will bene fit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a &qu ot\;refresh"\; overview of the complaint handling\, MDR and recall pro cess from start to finish\, including:
\n\n&bull\; Regulatory Affair
s Management
\n&bull\; Regulatory Affairs Specialist
\n&bull\; A
uditors
\n&bull\; Compliance Officer
\n&bull\; Compliance Specia
list
\n&bull\; Clinical Affairs
\n&bull\; Quality Assurance Mana
gement
\n&bull\; Marketing &\; Sales \;
\n&bull\; Distrib
utors/Authorized Representatives
\n&bull\; Legal Counsel
\n&bull
\; Engineering/Technical Services
\n&bull\; Operations/Manufacturing<
br />\n&bull\; Consultants