COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
HUMAN FACTORS AND DESIGN CONTROLS
FOR MEDICAL DEVICES AND COMBINATION
PRODUCTS
Instructors Michael Gross, Ph.D., RAC
Principal Consultant
Chimera Consulting North America LLC
in collaboration with Adam R. Shames, MBA
CEO at Core Human Factors, Inc.
May 27-28, 2015
Chemical Heritage Foundation Conference Center
315 Chestnut Street, Philadelphia, PA 19106
This training program is also available as an in-house training program.
For more information call 215-316-8394.
COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
Through interactive classroom lectures, discussion of case studies and sharing of experience,
this advanced training, covering medical devices and combination products (a combination of a
drug, device, or biological product), is intended to enhance participant understanding of the topics
listed below.
Human Factors:
 Optimizing your company's human factors design process through optimized design
validation practices that can be applied to every development project in order to reduce
development delays and improve the chances of first-time approval.
 How to utilize human factors studies, to identify design flaws, potential use errors and their
mitigations, during development of a new device or device constituent part of a combination
product, or when modifying an existing device constituent part to be used in a combination
product.
 Why it's never too late to consider applying human factors engineering principles. How to
validate the design of a legacy product.
 Understanding differences between CDRH, CDER, and CBER human factors expectations.
 How to establish reasonable human factors/design validation expectations with FDA
reviewers so that FDA review meetings have successful outcomes.
 The most common reasons why companies and FDA differ over product design validation
issues.
 How to write and submit a human factors design validation protocol to FDA.
 How to have a successful outcome for a human factors design validation study on the first
attempt.
 Pitfalls: Case study review and discussion of various human factors deficiencies cited by
FDA.
Combination Product Good Manufacturing Practice Regulations:
 How to comply with current Good Manufacturing Practice regulations, guidance and
standards, for medical devices and device-containing combination products and their
applicability to pharmaceutical and medical device developers, contract manufacturers and
constituent part and component part manufacturers.
 Interpretation, current guidance, draft guidance, industry best compliance practices, recent
inspectional experience and FDA enforcement action for medical devices and device
containing combination products.
 How to implement and utilize design controls, including design verification and validation
testing, during development of medical devices and device containing combination products.
 What to do about a Design History File for a legacy product.
WHO SHOULD ATTEND?
This training program is intended for individuals working in product development, engineering,
manufacturing, quality assurance and regulatory affairs roles in the pharmaceutical and medical
device industries. Participants will gain a comprehensive understanding of FDA’s regulation of the
development and manufacture of medical devices and combination products and how to interpret
guidance, conform to standards, comply with regulatory requirements and improve their ability to
manage complex product development and regulatory compliance problems.
COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
ABOUT THE INSTRUCTORS:
Michael Gross, Ph.D., RAC
Principal Consultant at
Chimera Consulting North America LLC
Michael Gross is the Principal Consultant of Chimera Consulting
North America LLC, a consultancy specializing in quality
assurance, regulatory affairs and technical development of drugs,
biologics, medical devices and in particular combination products.
Michael has worked in the medical products industry for over thirty years in senior quality,
compliance and regulatory affairs roles and has gained broad and deep understanding and
experience in the development and regulation of drugs, biologics, medical devices and
combination products. He has personally written and/or managed the submission of a variety of
investigational exemption applications, marketing applications and other FDA regulatory filings
and has made counterpart filings to European Health Authorities. He is a former FDA biologics
reviewer and inspector.
During the past 23 years Michael has provided an influential industrial perspective on the
regulation of combination products. He is a frequent speaker on combination products topics at
industry meetings and has published numerous articles in regulatory and scientific publications.
ADAM R. SHAMES, MBA
Founder and CEO at Core Human Factors, Inc.
Adam is a well recognized human factors expert and the founder
and CEO of Core Human Factors, Inc. He has an M.B.A. in
international business from the Fox School of Business and
Management at Temple University and a B.S. in human factors
engineering and psychology (double major) from Tufts University,
where he received the De-Florez Prize in Human Engineering.
Adam also has a Certificate in Applied Ergonomics Training from the United States Army Center
for Health Promotion and Preventive Medicine. He has over a decade of extensive research
experience, has conducted hundreds of usability studies with thousands of participants in cities
around the world, has been the Principal Investigator on numerous successful IRB reviewed
studies, and has worked as a consultant for over a decade.
COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
PROGRAM AGENDA
The formal program will begin at 10:00 AM the first day to allow additional arrival time for out-oftown participants who opt to travel that day. The program will end late the first day. The second
day will start earlier to allow traveling participants an early departure. Lectures will be interactive
and will provide ample time for Q&A and discussion. Case studies will be related to lecture topics
covered. Participants are encouraged to bring case studies and topics for discussion.
Day One
9:00 AM: Arrival, Registration, Continental
Breakfast
10:00 AM: Session 1 – Introduction,
background, combination product
regulatory overview
Day Two
8:00 AM: Arrival; Continental Breakfast
8:30 AM: Session 6 – Introduction to
human factors engineering
11:30 AM: Lunch
10:00 AM: Session 7 – Review of human
factors standards
12:30 PM: Session 2 – Current Good
Manufacturing Regulations for
drugs, devices and combination
products
10:30 AM: Session 8 – How to integrate
the required process into
product development
2:00 PM: Coffee Break
12:00 PM: Lunch
2:30 PM: Session 3 – Design Control
Requirements and Guidance for
Medical Devices and Device
Containing Combination Products
1:00 PM: Session 9 – How to conduct
the analysis and studies the
FDA requires
3:30 PM: Session 4 – Design Verification
and Validation Requirements and
Guidance Medical Devices and
Device Containing Combination
Products
2:30 PM: Coffee Break
4:30 PM: Session 5 – Case Studies,
discussion, Q&A
3:00 PM: Session 10 – Case Studies,
discussion, Q&A
5:30 PM: Conclusion of Day One
4:00 PM: Conclusion of Day Two
This workshop and others like it are also available as a one or two day in-house
workshops. For more information visit www.ChimeraConsultingNA.com (under
the “Training” tab) or call 215-316-8394.
COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
ABOUT THE CONFERENCE VENUE:
The Chemical Heritage Foundation Conference Center
The Conference Center at CHF (www.chemheritage.com) is located in the
heart of Old City Philadelphia in front of Independence National Historical
Park and near attractions such as the Liberty Bell, Independence Hall, and
the National Constitution Center.
The modern 13,500 square-foot venue
features sleek fully equipped meeting
rooms combining an award-winning
design with amenities required for
productive meetings. Catering is provided
by top-notch local caterers managed by
conference center staff. The conference
center is surrounded by museum artifacts reflecting scientific creativity,
innovation and the history of chemistry along with dramatic views of historic
Philadelphia. Transportation to the conference center is convenient with
easy access to Philadelphia International Airport, trains and I-95. Two hotels
are within a one block walking distance to the conference center.
For overnight accommodations, consider making reservations at a nearby hotel:
Omni Hotel at Independence Park
401 Chestnut Street
Philadelphia, PA 19106
Tel: 215.925.0000 or 800.843.6664
(Mention “Chimera Consulting” when
booking to receive discounted rate)
Hotel Monaco Philadelphia
433 Chestnut Street
Philadelphia, PA 19106
Tel: 800.546.7866
(Follow this link for a discounted rate:
https://gc.synxis.com/rez.aspx?Hotel=56
524&Chain=10179&promo=chhf)
General Information:
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•
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Final payment must be received by May 18, 2015.
Participant substitutions are welcome with 24 hour prior notice.
Cancellations - Course registration fees are refundable less a $250.00 service fee if
written notice is received before April 27, 2015; after this date a credit for a future
Combination Product Training Institute program will be issued.
Please notify Erica Chase at [email protected] if any
participants have special-needs.
COMBINATION PRODUCTS – UNDERSTANDING FDA REQUIREMENTS FOR THE DEVELOPMENT, REGISTRATION
AND MARKETING OF PREFILLED SYRINGES, DRUG DELIVERY DEVICES AND SYSTEMS
REGISTRATION
Please fill out online form or print this page, scan and fax or email a separate page/form
for each attendee. Fax: 215-545-6028 Email: [email protected]
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Course Fees (check the selection which applies):
___ I have paid in full before Monday, May 18, 2015: $2,060
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Email Erica Chase at [email protected] or call 215-316-8394 for
information about alternative payment methods, trouble with making payments, or
discounts available for multiple attendees from the same company.
For registration payment by check: Checks may be made payable to Chimera Consulting
North America LLC. Email [email protected] for mailing instructions.
Registration confirmation will be sent after full payment is received.
Chimera Consulting can send an invoice to your company, however full payment must be
received by May 18, 2015. Please provide:
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