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DTSTAMP:20240328T111018Z
UID:ab3cd7d6-d770-446b-96cb-89c7cced2f11
DTSTART:20210504T083000
DTEND:20210505T083000
CLASS:PRIVATE
DESCRIPTION:
Navigating the Maze for Post-Market Compliance -- Complaint
Handling\, MDRs\, Recalls and Proposed Guidance on FDA Risk Benefits
\n\nPost-Market activities\, Complaint Handling\, MDRs\, and Recalls ar
e expensive\, time consuming\, and often lead to more serious financial co
nsequences. Over 80% of FDA Inspection target observations for lack of com
pliance in these areas.
\n\nBy attending this seminar\, you will dis
cover:
\n\n\n - How to overcome one of the biggest obstacles devi
ce manufacturers face
\n - How the FDA expects you to develop and im
plement proper handling of complaints reportable or non-reportable\, produ
ct complaint handling and documentation
\n - How and when to file Me
dical Device Reports (MDR)\, effective and appropriate communication with
the appropriate regulatory agencies in the event of a recall.
\n - H
ow to conduct a correction and removal actions to avoid a recall crisis\,
including required recordkeeping\, expectation from FDA and other regulato
ry agencies in the event of a recall and key factors in implementing and m
aintaining compliance with the regulations and real life experiences of FD
A.
\n
\n
\nSpend one and a half days in an interactive course
led by Ms. Rita Hoffman\, Former FDA CDRH Recall Branch Chief with over 3
6 years with FDA and leading Industry Expert\, who will provide the partic
ipants with tools to minimize risk of regulatory enforcement actions.
\nDOWNLOAD BROCHURE
\n\n**New course materials have been added\, updated content will i
nclude:
\n\n\n - Creating Standard Operating Systems (SOPs) for P
ost-Market Quality Systems and
\n - What to expect from the changes
in ORA with Inspection Structure Realignment
\n
\n\n \;
\n\nThis Seminar will have you stop spinning your wheels with nonessent
ial activities\, and leave you with a comprehensive learning package that
only Rita Hoffman\, a former FDA CDRH Recall Branch Chief with experience
across the device\, drug and veterinary industries can provide.
\n\nLearning Objectives:
\n\n\n - Understand how to comply with com
plicated Compliant Handling\, MDR and Recall requirements
\n - Firms
MDR reporting and FDA'\;s handling of reports
\n - Company prepa
ration in the event of a Recall\, recall strategy\, notification letter an
d communicating with the FDA
\n - Minimize your risk of regulatory e
nforcement actions
\n - Assist with the creation and maintenance of
effective procedures for handling complaints\, reportable events and recal
ls
\n - Understand the relationship and interaction with other quali
ty system elements as they relate to complaints and reportable events
\n - Walk-through of case examples
\n - Step-By-Step guide to desi
gning Standard Operating Systems for communicating process for firm&rsquo\
;s success
\n - Discussion of FDA&rsquo\;s New Guidance&rsquo\;s on
Risk and how it interacts with Recalls
\n
\n \;\n\nWho Wil
l Benefit:
\n\nThis course will benefit anyone in the medical devic
e industry that handles functions involving product complaints\, recalls\,
medical device reporting.
\n\n\n - Regulatory Affairs
\n - QA/QC
\n - Project Managers
\n - Regulatory Professional
\n - Risk Managers
\n - Complaint Handling Teams
\n - CAPA T
eams
\n
\n
\nSeminar Fee Includes:
\nLunch
\nAM-PM
Tea/Coffee
\nSeminar Material
\nUSB with seminar presentation
\nHard copy of presentation
\nAttendance Certificate
\n$100 G
ift Cert for next seminar
\n \;\nTopic Background:
\n\nMedical Device Reporting (MDR) and recall compliance are critical to the
continue survival of all device manufacturers. The FDA is continuing their
efforts to issue numerous FDA Warning Letters and serious enforcement act
ions\, including criminal &\; civil penalties levied on companies that
failed to properly report events and take proper corrective and removal ac
tions. The number of device companies having their recall classified as a
Class 1 (most severe) recall has surged in the past three years. Additiona
lly\, product liability and financial risks are staggering when companies
fail to properly report and take action when required.
\n\nThis cour
se will provide an understanding of MDR &\; recall compliance and the i
nterrelationship of Complaint Handling\, CAPA\, and Risk Management proces
ses. It will be beneficial to all device manufacturers and is recommended
for any individuals or teams that are involved in medical device reporting
(MDR) and correction &\; removal processes\, including recalls.
\n\
nAGENDA
\nDAY 01(8:30 AM - 5:00 PM)
\n \;\
n\n - 08.30 AM - 09.00 AM: Registration
\n - 09.00 AM: Session
Start
\n - Introduction to class (20 min)
\n - Lecture 1: Com
plaint Handling and FDA Expectations (70 min)\n
\n - What is a comp
laint?
\n - Firms Responsibilities and Definitions
\n - Comp
laint Forms
\n - FDA Expectations for written procedures on complai
nt files
\n
\n \n - Lecture 2: Medical Device Reporting Pr
ocedures (MDR) (60 min)\n
\n - Understand the MDR regulation 21CFR
803
\n - Definitions 21 CFR 803.3
\n - MDR Procedures 21 CFR
803.17
\n - Types of MDR reports
\n - MDR reporting by firm
\, agents and exemptions
\n
\n \n - Lecture 3: MDR FDA Per
spective (30 min)\n
\n - CDRH Mandatory vs. Voluntary Reporting
\n - What happens to an MDR report submitted to FDA
\n - Manufa
cturer and User Facility Device Experience (MAUDE)
\n - Medical Pro
ducts Safety Network (MedSun)
\n
\n \n - Lecture 4: User E
rror Malfunction\n
\n - Identifying a Malfunction
\n - Malfu
nction --To report or not to report
\n - Serious injury triggers\n
- Person Qualified Makes Medical Judgment
\n
\n \n <
li>Lecture 5: Preparing Standard Operation Programs (30 min)\n - Le
cture 6: Recalls: Definitions and Legal Authority (45 min)\n
\n - W
hat is a recall?
\n - Legal Authority (Chapter 7\, 21CFR 806)
\
n - Voluntary vs. Mandatory recalls
\n - Definitions &ndash\; Co
rrections\, Removals
\n - Reporting requirements for non-recall fie
ld actions
\n - Classification system &ndash\; Classifying a Recall
?
\n - What is different about Class 1 recall
\n
\n \
n - Lecture 7: Being Recall Ready &ndash\;Proactive Steps to Avoid Crisi
s (45 min)\n
\n - Internal Decision Making
\n - Early warnin
g signs
\n - Assembling &ldquo\;The Team&rdquo\; &ndash\; Assigning
decision making authority
\n - Examples of Close-calls
\n - Guidelines and best practices for having contingency plan in place
\n
\n \n - Lecture 8: Evaluating Risk and Health Hazard Evaluati
on (HHE) (60 min)\n
\n - Analyzing adverse event and product qualit
y reports
\n - Identifying trends\, Data and factors to consider\n
- Assessing need to conduct HHE
\n - HHE Procedures
\n
- Human Factors Issues
\n - Opening a CAPA to Determine Root Cau
se
\n
\n \n
\n
\n
\nDAY 02(8:30 AM - 12:00 PM)
\n \;\n\n - Lecture 9: Developing effective Strategies and
Communicating with FDA (80 min)\n
\n - Elements of a good Recall S
trategy
\n - What does the FDA expect strategy to contain?
\n
- Effective Notification Letter to minimize consequences
\n - Kno
wing when to contact FDA District
\n - Discussing Recall Strategy w
ith FDA &ndash\; Seeking input and support of your strategy to avoid commo
n pitfalls
\n - Issuance of Press Release and communication with cu
stomers
\n
\n \n - Lecture 10: Silent Recalls vs. Product
Enhancements (20 min)\n
\n - Device changing environment
\n Product improvement (Repair or Modification)
\n - Decision 803 or
806
\n
\n \n Lecture 11: Product Retrieval Issues\, Eff
ectiveness Checks and Status Reports (50 min)\n \n - Receiving and
accounting for returned products
\n - Supply chain challenges &ndas
h\; distribution\, wholesale\, repackaging
\n - Global recall marke
t
\n - Designing an efficient Effectiveness Checks
\n - Coor
dination and Discussion with FDA
\n - Evaluating recall effectivene
ss Data
\n - Developing and formatting status reports
\n
\
n \n Lecture 12: New ORA Alignment and Inspection Changes (30 min
)\n Lecture 13: Termination of a Recall (15 min)\n \n - Wh
o\, how and when does termination happen
\n - Exporting a Recalled
Product
\n - Communication between firm and District Office
\n
- Requesting formal closeout by FDA
\n
\n \n Mock Rec
all and Wrap-up (35 min)\n\n\nSPEAKER
\n<
img alt="Rita Hoffman" src="https://static.complianceonline.com/images/pan
elists/132739/Rita%20Hoffman_90x112.jpg" />
\nRita Hoffman\, RAC\,
\nManaging Partner Regs &\; Recall Strategies\, LLC and Former FDA C
DRH Recall Branch Chief\nRita Hoffman\, RAC. Managing Partner Regs &
\; Recall Strategies\, LLC .Ms. Hoffman has more than 36 years of FDA expe
rience across the device\, drug and veterinary industries. She has an inti
mate understanding of FDA regulatory and compliance issues from the perspe
ctive of both FDA and regulated industry. As an FDA compliance consultant\
, she provides clients with regulatory insight\, advises on critical compl
iance deficiencies\, performs compliance and new product audits\, provides
insight and guidance on recall strategies to the medical device industry\
, and advises on jurisdiction determinations for combination products.
\n\nMs. Hoffman retired from the FDA in January 2011 as the Recall Bran
ch Chief for the Center for Devices and Radiological Health (CDRH)\, where
she was responsible for oversight and review for all medical device recal
ls. Ms. Hoffman held several positions including the Center for Drug Evalu
ation and Research (CDER) Jurisdiction Review Officer (providing guidance
on drug/device product designation\, combination products and co-packaging
)\, Acting Associate Ombudsman\, Small Business Liaison\, and was a Policy
Analyst for eight years in the Office of the Commissioner. She served as
co-chair of RAPS&rsquo\; Baltimore/Washington Metropolitan Area Chapter fo
r 2-terms\, and in 2008 was presented with the Special Recognition Award b
y RAPS.
\n\nPlease contact the event manager Marilyn (marilyn.b.turn
er(at)nyeventslist.com ) below for: \;
\n- Multiple participant d
iscounts \;
\n- Price quotations or visa invitation letters \
;
\n- Payment by alternate channels (PayPal\, check\, Western Union\,
wire transfers etc) \;
\n- Event sponsorship \;
\n
\nNO REFUNDS ALLOWED ON REGISTRATIONS \;
\nPrices may go up any
time. Service fees included in pricing. \;
\n--------------------
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\n--
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\n\n
VIO180217CEV
\n
SUMMARY:Navigating the Maze for Post-Market Compliance -- Complaint Handlin
g\, MDRs\, Recalls and Proposed Guidance on FDA Risk Benefits
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SUMMARY:Navigating the Maze for Post-Market Compliance -- Complaint Handlin
g\, MDRs\, Recalls and Proposed Guidance on FDA Risk Benefits
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