Course Registration
Director
Form
Who Should AttendCourse Offering # 1104-301
Additional
Faculty
Medical
Device Regulatory
Compliance
April 11–13, 2011 • New Brunswick, NJ
Dr. Mr. Ms.
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Since our founding in 1967, we have successfully trained nearly a half
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concepts to new advances and cutting-edge technology, and current
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The Center for Professional Advancement (CfPA) is the largest
accredited technical training organization in the world with a curriculum
of approximately 350 short
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in 18 industries including
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Pharmaceutical, Biotechnology, Medical Device, Chemical,
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P.O. Box 7077Courses of Interest
East Brunswick, NJ 08816-7077
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Priority Code:
520
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Tuition payable in US funds net of all charges includes continental breakfast,
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The Center for Professional Advancement has
been approved as an Authorized Provider by the
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practice internationally. The Center for Professional Advancement is
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sessions and submission of a course assessment/evaluation.
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The Center for Professional Advancement (CfPA)
is accredited by the Accreditation Council for Pharmacy
Education as a provider of continuing pharmacy education.
Continuing Education Units (CEU) will be awarded only upon
successful completion of the course, i.e., attendance at all the
formal sessions and submission of a course evaluation. The CEU rate is 0.1
CEU per contact hour; statement of credit will be mailed within six weeks.
You will have an opportunity to evaluate your successful completion of these
course objectives through a Learning Assessment. This program provides a
knowledge-based activity, applicable to both Pharmacists and Technicians.
ThisFirst
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course id# 2104First
Day Information
General
• Complaint Procedures for Medical Devices
course id# 1834
Exp. Date
DayValidation
• Design Control Third
and Product
Who We Are
course id# 1900
Cardholder Name
(As appears on card)
Signature
Course Location
Security
code
(3 or 4 digit code)
Credit card billing address (if different than above address)
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• ISO 13485, ISO 9001 and QSR Regulations for Medical Device
Companies
course id# 2106
Additional Faculty
C0-174
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Seco
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Fou
Medical Device
Regulatory
Compliance
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Fourth Day
Course Topics Include:
Research & Development
Manufacturing—the QSRs
n Marketing
n Regulatory Compliance
n 510(k) Reforms
n Enforcement Defense
n Interactive Workshop
n
n
SME Certified Manufacturing Engineers (CMfgE)
and Technologists (CMfgT) may earn 1.8
recertification credits for attending this program.
Certification is valuable to everyone in industry. It is
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a recognized method of maintaining knowledge and
skills in your field. For complete details on SME Certification, contact
service@sme.org One SME Drive, Dearborn, MI 48121, 1-800-733-4763
Directed by:
Suzan Onel, Esq.
Partner
K & L Gates LLP
The Center for Professional Advancement
P.O. Box 7077, East Brunswick, NJ 08816-7077
Phone: 732.238.1600 • Fax: 732.238.9113
E-mail: info@cfpa.com
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• Root Cause Investigation for CAPA
ID 1992
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course id# 2092Recommended Reading
Past
Participants Have Said:
• Risk Management Today: Complying with the ISO 14971:
2007 Standard
Course Director
April 11–13, 2011 Recommended Reading
New Brunswick, NJ
ASQ Certification: ASQ Certified Quality Engineers,
Reliability Engineers and Quality Auditors may earn
credits for attending this program, providing
Fourth itDay
Dayrecertification
is covered under one area of the body of knowledge in which
they are seeking recertification or is job enhancement.
• Combination Product Development: Safety/Registration/Approval
❏ Check (payable in U.S. funds to The Center for Professional Advancement)
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SAVE $200- Register
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course id# 2089
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Who Should Attend
Course Director
Director
Course
Because of its comprehensive
overview, this course will
be most valuable to medical device industry professionals in:
Director
RecommendedCourse
Reading
Recommended
Reading
Accreditations
Medical Device Regulatory
Compliance
COURSE OUTLINE
Learning Objectives
• Management
• Regulatory Affairs
Additional
Facultyand Development
Additional
Faculty
• Compliance
• Research
• Quality Assurance
• Quality Control
• Clinical ResearchCourse Description
Text
Text
The course will also be helpful
for those who are new to the
industry or to their current position and do not have an inWe its
Areworkings; as well as for
depth knowledge of the Who
FDA and
more experienced personnel, including middle and upper
First
Day their knowledge of FDA
First
Day
management, to update and
broaden
Who
Should
Attend
requirements.
Course Location
Third Day
Day
Third
Learning Objectives
Course Director
Upon completion of this course, you will be able to:
• Identify FDA’s
and postDescription
market
requirements
Pastpre
Participants
Have
Said:
Past
Participants
Have
Said:
Course
Additional Faculty
• Prepare FDA submissions including 510(k)s, PMAs, and
IDEs
Who
We
Are
• Manage the FDAWho
inspection
process
Should
Attend
Text
• Appy the QSR to meet your company’s obligations
• Anticipate future trends
in FDA
compliance expectations
Course
Location
Objectives
and enforcementLearning
First
Day
CourseDescription
Director
Course
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First Day
Day
First
Course Director
Ways To
To Additional
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General
8:00 a.m.: Registration/Continental
Breakfast
Third Day
Second
Dayin the global law firm K&L Gates LLP.
Suzan Onel is
a Partner
Who Should
Attend
Ms. Onel leads the device practice in Washington, DC and
Additional
Faculty
has two decades of experience in FDA-regulated matters. Ms.
Onel's practice
covers
all issues related to FDA including food,
Fourth
Day
drug, medical device,
dietary supplements,
Learning
Objectives and cosmetic law.
She routinely counsels domestic
Textand international companies
on market entry strategies, premarket applications and
Second Daylabeling, promotional activities, regulatory
notifications,
Courseinvestigations,
Descriptionrecalls, and
compliance, due diligence
enforcement defense. Ms. First
Onel'sDay
experience includes
extensive
interaction
with
the
U.S.
Food and Drug
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Administration, the Federal
Commission, the Consumer
WhoTrade
We Are
Product Safety Commission, the National Advertising Division
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of the Better Business Bureaus, and similar state and
international bodies.
SheShould
is a frequent
author and lecturer on
Who
Attend
Course
Location
FDA matters including
combination
products, medical device
software, dietary supplements, and functional foods. She
received herPast
Bachelors
degree withHave
honorsSaid:
in neurobiology
Participants
Objectives
and history from Learning
the University
of Pennsylvania and her law
Course Director
degree from the University of Virginia School of Law.
First Day
April 11–13, 2011 • New Brunswick, NJ | Offering# 1104-301
Second Day
Day
Second
Information
Four ninety-minute sessions will be
devoted
current
good
manufacturing
Fourth
Day
FirsttoDay
Fourth
Day
practices in the medical device industry
8:30–10:00 a.m.:
as required by the Quality System
Introduction to the FDA/FDA Course Co-Directors
Regulation (21 CFR Part 820). Through
Enforcement Policies and Procedures/
Third
Second
Day techniques, including
Second
Day
a variety
ofDay
learning
Freedom of Information Act/Review of
lecture, class discussion, and problem
Accreditations
Learning Objectives: Laws, Regulations,
solving, the following topics will
Recommended Reading
Operational Procedures and Organization;
be addressed:
Foundation and Legal
Fourth Day
Day
Fourth
Relationships with Other Federal
Authority of the QSR, International
Agencies, States, and the International
PastofParticipants
Said:Quality
Courses
Interest
Applicability,Have
Terminology,
Community; Legal and Administrative
3 Ways To Register
System Requirements, Design Controls,
Remedies; Regulations, Guidelines;
Document Controls, Purchasing Controls,
Guides; The Freedom of Information
Identification and Traceability, Production
General
Information
Act—How to Obtain and Use Information,
Controls, Acceptance
SecondActivities,
Day
First
Day
How to Guard Against Unwarranted
Nonconforming Products, Corrective and
Disclosure
Preventive Actions, Handling, Storage
Course
Co-Directors
and Installation, Packaging and Labeling
10:30–12:00 noon:
Accreditations
Fourth
Day
Third Day
Controls, Records,
and Servicing.
Classification Process
510(k)
Submissions and 510(k) Reforms:
8:00–9:30 a.m.:
Classification and Reclassification;
Exempt
Recommended
Reading
Courses of Interest
Quality
System
Devices; 510(k)s; IDEs; Regulatory
Second
DayRegulation (Part 1)
Standards; Restricted Devices; Custom
10:00–11:30 a.m.:
Devices; Third Party Review, Electronic
Quality System Regulation (Part 2)
Products
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Third Day
Third Day
8:30–10:00 a.m.:
Medical Device Marketing: Device
Manufacturing; Registration; Listing;
Labeling; Promotion and Advertising;
Unapproved Use Information
10:30–12:00 noon:
Enforcement Issues, Import and Export:
Warning Letters and Responses;
Application Integrity Program; FTC
Actions; Banned Devices; Practice of
Medicine; Export and Import
1:00–2:30 p.m.:
Post-Market Issues: FDA Notifications re
Field and Headquarters Responsibilities;
Field Inspectional Guidelines; Electronic
Identification/ Records; MDRs;
Corrections and Removals; Section 518
Notifications and Remedies; User
Reports; Device Tracking; Interacting with
the FDA Center
Course
Description
Additional
Faculty
Martha Bennett, RAC, Consultant, Bennett & Company
Who We Are
Anthony T. Pavel, Partner, Text
K&L Gates LLP
Course
Location
First
Day
Assessment Opportunity
General Information
Fourth Day
1:00–2:30 p.m.:
12:30–2:00 p.m.:
Pre-Market Approval Applications
Quality System Regulation (Part 3)
Second Day
(PMAs) and Product
FirstDevelopment
Day
Course Co-Directors
Protocols (PDPs): PMAs; PDPs; PMA
2:30–4:00 p.m.:
Supplements; IDEs; Data Availability;
Quality System Regulation (Part 4)
Advisory Panels; Humanitarian Use
Fourth Day
Third
Day
Recommended
Reading
Devices; Access to Unapproved
Products
4:30–6:00 p.m.:
Interactive Workshop
3:00–4:30 p.m.:
The FDA Inspection and Bioresearch
Monitoring: Investigators as Fact3Finders
Ways To
and Documenters of Evidence; Their
Power and Limitations; Types of
Inspections; Responding to an FDA
First
Day and the Form
Inspection; The Exit
Interview
FDA-483; Providing a Written Response
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Past Participants Have Said:
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www.cfpa.com
Client Site
Online Training Now Available
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Training at your site and at your convenience. For furtherSecond
information,
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please contact Client Site Programs: Direct Dial (USA) +1/732.238.1600,
ext. 4547; or fax +1/732.238.9113; or E-mail clientsite@cfpa.com.
A convenient and cost-effective way to experience our accredited
training, easily access the knowledge you need through the Internet. For
a list of upcoming courses visit www.cfpa.com/online-training.
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© The Center for Professional Advancement 2011
This continually updated course covers current FDA
regulatory compliance
issues withFaculty
respect to developing,
Additional
Who We
Are devices. It includes an
manufacturing, and marketing
medical
overview of Past
the FD&C
Act, case law,Have
and pertinent
Participants
Said: FDA
regulations. Among the many topics to be discussed will be:
Text
FDA’s regulatory policies,
how
they develop and where they
Course
Location
are documented; potential FDA enforcement for
noncompliance including warning letters, injunctions, seizures,
civil penalties, and criminal prosecutions; device classification
First
Day
Course
Director
and reclassification; premarket
submissions requirements for
510(k)s, IDEs, PMAs, and PMA Supplements; device
promotion and advertising; post market requirements
Third Faculty
Day
including establishment registration,
device listing, and
Additional
adverse event reporting; inspections; recalls; and the QSR,
including design controls and process validation. The course
will focus on the application of the law, regulations, and
policies to medical devices. Text
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This course will be held in the Hyatt Regency located in New
Brunswick, New Jersey. Participants must, however, make
Coursecost
Director
Day
their own reservations; theThird
of
hotel accommodation is not
included in the course fee. Hotel information will be included
with your acceptance. To receive CfPA’s rate and room block,
request The Center
for Professional
Advancement individual
Additional
Faculty
traveler’s rate OR book reservations online and enter our
Participants
Said:
Corporate Past
Rate Number:
63172 in Have
the Corporate/Group#
on
the Reservations page. For reservations call 800.233.1234;
Text
outside U.S. call 732.873.1234.
First Day
With focus on the applications of
Third Dayand policies
the law, regulations
to medical devices
Past Participants Have Said: