Course Registration
Director
Form
Who Should AttendCourse Offering # 1203-303
Additional
Faculty
Medical
Device Regulatory
Compliance
March 12–14, 2012 • New Brunswick, NJ
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*
$
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Tuition payable in US funds net of all charges includes continental breakfast,
luncheon, breaks and course notes.
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is per Should
person, for twoAttend
or more enrollments registering at the same time, from
* Group Rate
the same company, for the same course.
Note: Payment is due before course start date.
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• Combination Product Development: Safety/Registration/Approval
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Course
course id# 2104
General Information
• Complaint Procedures for Medical Devices
course id# 1834
Exp. Date
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• Design Control and Product Validation
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location – VIA EMAIL. We recommend that travel/hotel arrangements not
be made until final confirmation package is received. If confirmation is not
received two weeks prior to the course please contact Customer Service.
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Cancellations/Substitutions/FEES: ALL cancellations, refunds and credits
are subject to a $200.00 processing fee. Applicants may cancel up to four
(4) weeks prior to the course start date for a refund. Applicants that cancel
less than four (4) weeks prior to the course will be issued a credit that can
Firsttowards
Day a future course up to one year from the date ofSecond
be used
issuance.Day
No refunds or credit will be issued for those who cancel less than ten (10)
working days before the course start date and/or do not attend the
scheduled course. Substitutions are permitted at any time. If for any
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reason,
CfPA
for Day
airfare, hotel or other costs incurred by the registrant. Program content,
schedule and instructors are subject to change without notice.
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course id# 1900
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• Root Cause Investigation for CAPA
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The Center for Professional Advancement has
been approved as an Authorized Provider by the
International Association for Continuing Education
and Training
(IACET),
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Day1760 Old Meadow Road,
Suite 500 McLean, VA 22102. In obtaining this
approval, The Center for Professional
Advancement has demonstrated that it complies with the ANSI/IACET
Standards which are widely recognized
standards of good practice
Thirdas Day
internationally. The Center for Professional Advancement is therefore
authorized to offer IACET CEUs for its programs that qualify under the
ANSI/IACET Standards. CEUs will be awarded only upon successful
completion of the course, i.e., attendance at essentially all the formal training
and a minimum score of 70% on the assessment.
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Recommended Reading
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.
Second
ThisFirst
Program#
offers aDay
Day0716-0000-12-181-L04-P, 0716-0000-12-181-L04-T
total of 18 contact hours.
3 Ways To Register
SME Certified Manufacturing Engineers (CMfgE)
and Technologists (CMfgT) may earn 1.8Fourth Day
recertification credits for attending this program.
Certification is valuable to everyone in industry. It is
a recognized method of maintaining knowledge and
skills in your field. For complete details on SME Certification,
contact
Second Day
service@sme.org One SME Drive, Dearborn, MI 48121, 1-800-733-4763
March 12–14, 2012Recommended Reading
New Brunswick, NJ
3 Ways To Register
First Day
Seco
Third Day
Fou
Medical Device
Regulatory
Compliance
Second Day
Fourth Day
Course Topics Include:
Research & Development
Manufacturing—the QSRs
n Marketing
n Regulatory Compliance
n 510(k) Reforms
n Enforcement Defense
n Combination Products
n Interactive Workshop
n
n
Third Day
ASQ Certification: ASQ Certified Quality Engineers,
Reliability Engineers and Quality Auditors
may Day
earn
Fourth
recertification credits for attending this program, providing it
is covered under one area of the body of knowledge in
which they are seeking recertification or is job enhancement.
Directed by:
Suzan Onel, Esq.
Partner
K & L Gates LLP
Past
Have Said:
courseParticipants
id# 2092Recommended
Reading
course id# 2106
Course Director
Accreditations
Texts
Course&Co-Directors
Pay by Jan 16
SAVE $200- Register
• ISO 13485, ISO 9001 and QSR Regulations for Medical Device
Companies
• Risk Management Today: Complying with the ISO 14971:
2007 Standard
ID 1992
Since our founding in 1967, we have successfully trained nearly a half
Director
million people worldwideCourse
in topics ranging
from basic and introductory
concepts to new advances and cutting-edge technology, and current
U.S. and European regulations. CfPA courses are offered in a variety
of formats – Public offering, Client Site and Online – to fit you or your
company’s training needs.
Additional Faculty
Course Co-Directors
Who Should Attend
Discounts/Rates: To receive the Early RegistrationFourth
Discount,Day
payment is
required at time of registration and/or BEFORE early registration discount
expires or the regular tuition rate will apply. If choosing invoice/check/
wire transfer, payment must be received prior to expiration of early
registration discount or the regular tuition rate will apply. All tuition prices
are a per person rate. To qualify for the Group Rate tuition, registration
must be for two or more enrollments registering at the same time, from
the same company, for the same course. Multiple discounts not applicable.
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Regular Registration
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• Mail registration form to:
Payment: Tuition payable in US funds net of all charges. Payment is due
BEFORE course start date. If payment has not been received two weeks
before the course, a credit card will be required to guarantee registration.
Last Name
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Early Registration
First(Save
Day$200)
The Center for Professional Advancement (CfPA) is the largest
accredited technical training organization in the world with a curriculum
of approximately 350 short
coursesLocation
in 18 industries including
Course
Pharmaceutical, Biotechnology, Medical Device, Chemical,
Cosmetics, Food and more.
• Fax registration form to: 732.238.9113
General Information
First Name
Tel
Accreditations
• Internet: www.cfpa.com
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Job Title
Who We Are
The Center for Professional Advancement (CfPA)
P.O. Box 7077Courses of Interest
East Brunswick, NJ 08816-7077
Learning Objectives
Texts
Priority Code:
520
(Please use this code when registering)
Course Description
Dr. Mr. Ms.
3 Ways To Register
course id# 2089
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
www.cfpa.com
www.cfpa.com
Courses of Interest
Recommended
Reading
Who We Are
Learning
Course Objectives
Location
Who Should Attend
Course
CourseDescription
Director
Because of its comprehensive
overview, this course will
be most valuable to medical device industry professionals in:
Accreditations
Medical Device Regulatory
Compliance
COURSE OUTLINE
Learning Objectives
• Management
• Regulatory
Affairs
Who We
Are and
Additional
Faculty
• Compliance
• Research
Development
• Quality Assurance
• Quality Control
• Clinical ResearchCourse Description
Course Location
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
CourseFirst
Director
Day
management, to update and broaden their knowledge of FDA
Who
Should
Attend
requirements.
Course Location
Additional
ThirdFaculty
Day
Learning Objectives
Course Director
Upon completion of this course,
Text you will be able to:
• Identify FDA’s
and postDescription
market
requirements
PastpreParticipants
Have
Said:
Course
Additional Faculty
• Prepare FDA submissions including 510(k)s, PMAs, and
IDEs
First Day
Who We
Are
• Manage the FDA inspection
process
Texts
• Apply the QSR to meetThird
your company’s
obligations
Day
Should
Attend expectations
• Anticipate futureWho
trends
in FDA
compliance
Course
Location
and enforcement
First Day
• Explain FDA’s Classification Process for devices and
Learning Objectives
Past
Participants
Have Said:
combination
products
Course Director
Third Day
Course Description
Additional Faculty
First Day
First Day
Course Director
General
3 Ways Information
To Register
Course Location
Recommended Reading
Suzan Onel is a Partner and Chair of the FDA Practice in the
March 12–14, 2012 • New Brunswick, NJ | Offering# 1203-303
Courses of Interest
3:00–4:30 p.m.:
Course Co-Directors
Second
Course
Director
The FDA
Inspection
andDay
Bioresearch
Monitoring: Investigators as Fact Finders
General Information
8:00 a.m.: Registration/Continental
and Documenters of Evidence; Their
Reading
Breakfast
Power and Limitations;
Types of
Fourth Day
Third Day Recommended
Additional
Faculty
Inspections; Responding to an FDA
8:30–10:00 a.m.:
Inspection; The Exit Interview and the Form
Course Co-Directors
Review of Learning Objectives
FDA-483; Providing a Written Response
Second
Introduction to the FDA/FDA 3 Ways To Register
Text Day
Enforcement Policies and Procedures/
Accreditations
Freedom of Information Act: Laws,
Recommended Reading
Regulations, Operational
Second Day
First DayProcedures and
Fourth
Day
First
Day
Organization; Relationships with Other
Courses of Interest
Federal Agencies, States, and the
Four ninety-minute sessions will be
3 Ways To Register
International Community; Legal and
devoted to current
good
Fourth
Daymanufacturing
Third
Day
Administrative Remedies; Regulations,
Third inDay
practices
the medical device industry
Guidelines; Guides; The Freedom
of
as required by the Quality System
General
Information
Information Act—How
to Obtain and Use
Second
First Day
Regulation (21 CFR
PartDay
820). Through
Information, How to Guard Against
Second
Day techniques, including
a variety
of learning
Unwarranted Disclosure
lecture, class discussion, and problem
Course
Co-Directors
Past
Participants
Said:
solving, the Have
following
topics
Fourth
Day will
Third Day
10:30–12:00 noon:
be addressed:
Foundation
and Legal
Fourth Day
Classification Process 510(k)
Authority of the QSR, International
Accreditations
Submissions and 510(k) Reforms:
Applicability, Terminology, Quality
Recommended
Reading
Classification and Reclassification;
Exempt
Second
Day
System
Requirements,
Design Controls,
Devices; 510(k)s; IDEs; Regulatory
Document Controls, Purchasing Controls,
Standards; Restricted Devices; Custom
Identification and Traceability, Production
Courses of Interest
Devices; Combination Products (Drug3 Ways To Register
Controls, Acceptance Activities,
Fourth Day
Device); Third Party Review; Electronic
Nonconforming Products, Corrective and
Products
Preventive Actions, Handling, Storage
1:00–2:30 p.m.: First Day
General Information
and Installation, Packaging and Labeling
Second Day
Controls, Records, and Servicing.
Pre-Market Approval Applications
(PMAs) and Product Development
8:00–9:30 a.m.:
Course
Protocols (PDPs): PMAs; PDPs;
PMA Co-Directors
Day (Part 1)
Quality System Fourth
Regulation
Third Day
Supplements; IDEs; Data Availability;
Advisory Panels; Humanitarian Use
10:00–11:30 a.m.:
Devices; Access to Unapproved
Products
Recommended
Reading
Quality System Regulation (Part 2)
2:30–4:00 p.m.:
3 4)
Ways
Quality System Regulation (Part
To
4:30–6:00 p.m.:
Interactive Workshop
First 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
3 Ways To Register
Fourth Day
First Day
Second Day
Third Day
FourthOnline
Day Training Now Available
Second Day
Martha Bennett, RAC, Consultant, Bennett & Company
Who We Are
Anthony T. Pavel, Partner,Texts
K&L Gates LLP
Course
Location
First
Day
Assessment Opportunity
12:30–2:00 p.m.:
Quality System Regulation (Part 3)
Training at your site and at your convenience. For further information,
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.
Course
Description
Additional
Faculty
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
Second Day
Client Site
global law firm K&L Gates LLP. Ms. Onel leads the device
Additional Faculty
practice in Washington, DC and has over two decades of
experience in FDA-regulated matters. Ms. Onel's practice
Register
Who Should Attend
covers all issues related to FDA including food, drug, medical
device, dietary supplements,
and cosmetic law. She routinely
Texts
counsels domestic and international companies on market
Second
Day applications
entry strategies,
premarket
and notifications,
Learning
Objectives
labeling, promotional activities, regulatory compliance, due
Firstand
Dayenforcement defense. Ms.
diligence investigations, recalls,
Onel's experience
includes
extensive interaction with the U.S.
Fourth
Day Description
Course
Food and Drug Administration,
the Federal Trade Commission,
the Consumer Product Safety
Commission,
the National
Third
Day
Advertising Division of the Better Business Bureaus, and
Second
Day
similar
state
and international
bodies.
Who We
Are She is a frequent author
and lecturer on FDA matters including combination products,
medical device software, dietary supplements, and functional
Past
Participants
Haveof Said:
foods.
SheDay
is also
an editor
and author
the treatise,
Fourth
Who
Should
Attend
Location
Medical Device LawCourse
and Regulation
Answer Book 2011-12
published by PLI (2011). Ms. Onel received her Bachelors
degree with honors in neurobiology and history from the
Learning
University of Pennsylvania
her law degree from the
CourseandObjectives
Director
University of Virginia School of Law.
www.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.
© The Center for Professional Advancement 2012
This continually updated course covers current FDA
Past Participants
Have toSaid:
regulatory compliance
issues with respect
developing,
Who We
Are devices. It includes an
manufacturing, and marketing
medical
Text
overview of the FD&C Act, case law, and pertinent FDA
regulations. Among the many topics to be discussed will be:
FDA’s regulatory policies,
how Location
they develop and where they
Course
are documented; potential FDA
for
Firstenforcement
Day
noncompliance including warning letters, injunctions, seizures,
civil penalties, and criminal prosecutions; device classification
Course
Director
and reclassification; premarket
submissions requirements for
Third
Day
510(k)s, IDEs, PMAs, and combination products; device
promotion and advertising; post market requirements
including establishment registration, device listing, and
Additional Faculty
adverse event reporting; inspections; recalls; and the QSR,
including design
and process
validation.
Pastcontrols
Participants
Have
Said:The course
will focus on the application of the law, regulations, and
policies to medical devices. Texts
Course Co-Directors
This course will be held in the New Brunswick, New Jersey
area. Specific hotel information will be sent to you in your final
Course
Director
Third
Day
confirmation package which
will be
emailed to you
approximately three (3) weeks prior to the course start date.
Please note that participants must make their own hotel
reservations; the cost
of the hotel
accommodations is not
Additional
Faculty
included in the course fee. We recommend that travel/hotel
Past
Have
Said: package is
arrangements
notParticipants
be made until final
confirmation
received.
Texts
First Day
With focus on the applications of
the law, regulations
and policies
Third Day
to medical devices
Past Participants Have Said: