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PROFESSIONAL
DEVELOPMENT AND INDUSTRIAL TUTORIALS
Half-Day: $75
Full-Day: $150
Who/What Top Employers Hire:
An Interactive Workshop, Rosemarie Christopher
September 1, Afternoon
Learn the competitive truths behind the real hiring practices of
today’s top U.S. employers. Rosemarie
Chistopher, veteran executive recruiter and president of Med Exec
International (MEI), one of the nation’s leading executive placement firms,
reveals that “far from being a mystery or a closely guarded secret, hiring
the top performer is fairly straightforward” and must be understood from the
rationale of the employer. This
workshop is an interactive two-part roundtable session.
In the first session, attendees determine what traits and
characteristics they would require from a top performer in their field or
position. The second simulates
live interviews based on the information assessed in the first session.
Fifteen Strategies for
Engaging Your Audience, Michelle Paganini
September 1, Morning
We have all been faced with the
prospect of needing to share technical or regulatory information with a group
of our colleagues, customers or other key players. We wonder how we can keep our audience engaged, and share our
most important points in a clear and concise manner. We may even fantasize that after our presentation, people
will leave the room in a buzz of excitement, clearly understanding the point
of the presentation and feeling compelled to take action as a result!
The strategies for engaging an audience that we will explore fall into
three key areas: 1) Before you even
set foot in front of your audience, 2) Designing your presentation materials,
3) In front of your audience. If
you would like to upgrade your presentation skills and engage your audiences,
please join us for this practical and interactive session.
From
Lightbulb to Launch, Royce Johnson
September 1, Morning
As
bioengineers, we focus on developing new science.
The path from science to product, by which the value of our work is
ultimately translated into tools for clinicians, is arduous and rarely
discussed in academic environments. Many
issues must be resolved prior to a new technology being
"productized". This
workshop focuses on the elements required to convert a discovery to a product,
including business models, value propositions, product definition, and
regulatory requirements. Techniques,
such as Voice of the Customer and QFD, are discussed to aid in the successful
creation a new product.
Project Management
in a Regulated Industry: Design Control and Risk Management
(Joint workshop with American Society for Quality (ASQ), Carol Curran
and Bruce Hagger, September 1 (Full day)
This program is designed to familiarize the R&D engineer with
the Design Control regulations of the Food and Drug Administration and the
requirements of ISO 13485. Following the program, the engineer will understand the
basics of Design Control, how they apply to their products, and be able to
develop products effectively in this environment.
The program also incorporates a section on risk management based on ISO
14971 and the FDA’s current thinking on risk management.
Clinical
Engineering Practices Review, Yadin David, Elliot Sloane, September 1 (Full
day)
This
workshop is designed for practicing engineers in hospitals, industry and
government organizations who is considering Clinical Engineering certification
or would like to learn how to implement and measure performance of safe and
effective medical technology management and assessment programs. The workshop
faculty will share with the registrants proven principles and methodology of
administrating a successful medical equipment management program in large US
medical center and other countries.
Root Cause Analysis and
Failure Investigations Workshop, Organizer: Grey Meyer, September 1 (Full day)
This class covers the principles and practices of
non-conformance and customer complaint reporting and investigation within a
quality system starting with a discussion of statistical process control
basics leading to practical exercises designed to ensure that all attendees
acquire skills necessary to document and investigate all forms of
non-conformances to generate effective Corrective and Preventive Action (CAPA).
Investigation techniques including root cause determination by Man, Method,
Machine or Material and fishbone diagrams are discussed.
Quality
System Training – What Engineers Need to Know
(September 1, Full Day)
The goal of the workshop is to
provide current information on quality system requirements based on FDA’s
Quality System Regulation (QSR), 21 CFR 820.20, for Medical Device companies.
The intended audience includes:
All engineering professionals and support personnel working for a
medical device company,
including
manufacturing, quality and software engineers
Electrical, safety, and
reliability professionals who support manufacturing or other quality system
activities
Technicians
and other professional who support validation and verification activities
Anyone supporting, analyzing,
or implementing corrective and preventive actions
The class will challenge both
beginners and compliance experts to apply quality system requirements to
company activities.
By the end of the 6 hour workshop, students will be able to:
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Identify current FDA QSR
compliance issues and hot topics
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Identify/refresh QSR
requirements, tips, and pitfalls, for each subpart of the regulation
·
Identify the FDA QSR
requirements which apply to your job responsibilities
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Reference FDA QSR
guidance documents on the FDA website (www.fda.gov/)The
workshop will feature an interactive presentation, focusing on requirements
and current QSR compliance issues, drawing on the experience and questions
from the participants.
Healthcare Wireless - Introduction of
Mobile Application and Solutions in Hospital Setting, Yadin David, Jef
Youngflesh, T. Moreno, other Sprint engineers,
September 1, evening
This workshop will review recent applications of wireless technology in
improving work processes and communications within the demanding environment
of the healthcare delivery. Case
studies and users reports will be used to illustrate concept of mobile
applications. Faculty, from industry and clinical fields, will use case
studies to describe processes of site preparation and system specification.
Review of the relevance of adding RF spectrum into healthcare institutions for
mobile voice and data access improvements and solutions will be included.
Targeted audience is from Biomedical and Clinical engineering,
Telemedicine, RF, Informatics, Administration and Telecommunications decision
makers.
Pulse
Oximetry Technology -
Current Clinical Applications and Future Enhancements, Yadin
David, Paul Mannheimer, September 2, evening
Collaborating industry-based and clinical engineers experienced in the field
of pulse oximetry technology, will deliver workshop on the evolution of
pulse oximetry. Designed specifically for clinical/biomedical engineers,
professional healthcare providers and IT professionals. Instruction
includes lectures, case studies, and discussion by participants. The
program has five instructional components:
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