[May 27, 2016] |
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FDA's Low-Risk Device Policy and the Impact on Mobile Medical Device Applications Webinar - Research and Markets
Research and Markets has announced the addition of the "FDA's
Low-Risk Device Policy and the Impact on Mobile Medical Device
Applications - Webinar" webinar to their offering.
This webinar will provide the attendees with an overview of both FDA's
Low-Risk Device Draft Policy (January 2015) and guidance on Mobile
Medical Applications (February 2015), along with insight as to how
companies can achieve compliance with both.
FDA's existing oversight approach considers functionality instead of
platform. Only those mobile applications that are medical devices and
have functionality that could pose a risk to a patient's safety if they
did not function as intended will be regulated by FDA. FDA refers to
this subset of mobile applications as mobile medical applications.'
The attendees will learn what types of mobile medical devices are
subject to FDA oversight, the risk they pose to the public if they fail,
and how strictly the Agency will enforce its regulations. We will
explore the low-risk mobile medical devices over which the FDA has
discretionary enforcement. In addition, we will provide an overview of
the validation work required for mobile medical devices, similar to what
is required for computer systems subject to FDA regulation.
Objectives of the Presentation:
- Gain an understanding of how FDA classifies and regulates mobile
medical devices
- Understand the best practices for ensuring that a mobile medical
device is thoroughly tested and validated in compliance with FDA
regulations
- Learn how to develop the appropriate computer validation strategy when
dealing with mobile medical applications to ensure a good balance of
cost vs. risk
- Understand how to effectively document the process of computer system
validation, and maintain current information about mobile medical
applications
- Learn how to gain information about trends in validation of mobile
applications, as industry progresses and new best practices emerge
- nderstand some of the key "pitfalls" to avoid when applying the
concepts of computer system validation to mobile applications
- Understand the industry best practices for implementing and using
mobile medical applications, including examples
This webinar is intended for those working in the Medical Device
Industry, as well as other FDA-regulated industries, including
pharmaceutical, biological, animal health and tobacco. Functions that
are applicable include research and development, manufacturing, Quality
Control, distribution, clinical testing and management, adverse events
management and post-marketing surveillance.
Who can Benefit:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- This webinar will also benefit any consultants working in the tobacco
or life science industries who are involved in computer system
implementation, validation and compliance.
Topic Background:
The Food and Drug Administration (FDA) recognizes the extensive variety
of medical devices and mobile applications that operate in tandem. The
rapid pace of innovation provides both benefits and risks to public
health.
As mobile platforms become more user friendly, computationally powerful
and readily available, manufacturers have been developing mobile
applications of greater complexity to leverage the fact that these
devices are portable. Some mobile applications target individuals who
require assistance in their own health and wellness management, yet
others are for healthcare providers to use as tools to improve and
facilitate the delivery of patient care.
The FDA has formally classified certain types of software applications
that meet the definition of a device and, through classification,
identified specific regulatory requirements that apply to these devices
and their manufacturers. These include products that feature one or more
software components, parts, or accessories (such as electrocardiographic
(ECG) systems used to monitor cardiac rhythms, as well as devices that
are composed solely of software (such as laboratory information
management systems).
Key Topics Covered:
- Mobile medical applications and classification by FDA
- Low-risk mobile medical applications and FDA enforcement
- When and how FDA's general wellness/low-risk guidance should be applied
- An overview of FDA's regulation of mobile apps
- What the draft wellness/low-risk guidance means in relation to the
draft guidance for mobile applications
- Comparisons between the draft wellness/low-risk policy and FDA's
medical mobile application guidance
- GxP systems regulated by FDA
- Computer System Validation (CSV) methodology
- System Development Life Cycle (SDLC) framework
- Validation Strategy and Planning
- System Risk Assessment and Mitigation
- GAMP 5 System Classification and "V" Model
- Potential Pitfalls for Implementing and Using Mobile Applications in
an FDA-regulated Environment
- Industry Best Practices for Implementing and Using Mobile Applications
in an FDA-regulated Environment
For more information visit http://www.researchandmarkets.com/research/dgj36p/fdas_lowrisk
View source version on businesswire.com: http://www.businesswire.com/news/home/20160527005458/en/
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