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seminars

2-day In-person Seminar :

FDA Device Software Regulation


Casper Uldriks
January 22nd - 23rd, 2015
Course "FDA Device

Software Regulation" has been pre-approved

Los Angeles

by RAPS as eligible for up to 12 credits towards a participant's RAC


recertication upon full completion.

February 26th & 27th, 2015


Boston, MA

About GCPseminars:
GCPseminars is a training source that delivers diverse, high quality regulatory & compliance trainings. These
trainings are simple while being relevant and cost-effective while being convenient. GCPseminars imparts
knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars,
conferences and tailored, individualized consulting. These help organizations and professionals implement
compliance programs that meet regulatory demands and put business processes in place. Through our trainings,
we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn
or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio
Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes
companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune
500 companies. Professionals who undergo trainings from GCPseminars exhibit a vastly improved quality of life in
which there is increased productivity and professional growth. Some 30,000 professionals have gained from more
than 500 training courses we have conducted till now

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seminars
Overview :
Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit.
Problems with software create a number of different hurdles. Software may be a standalone device, control a device's
performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions
regarding patient management and treatment.

Agenda:
Day 1:

Day 2:

Lecture 1: FDA authority and regulatory program

Lecture 1: Cybersecurity

Types of Software are devices

Device vulnerabilities: malfunction and failure

Regulatory strategy

Pre-emption design

Risk classication

Latent malware/virus

Function and outcome

Post-event management

Medical Device Data Systems (MDDS)

Corrective action for software

Ofce of the National Coordinator (ONC) for Health

Disclosure to users

Information Protection

National Institute of Science and Technology Report

Software regulatory applications


FDA Guidance

Lecture 2: Medical Mobile Applications (mobile

Premarket submissions
Paradigms: aeronautics

Quality System Regulation (QSR)

apps)
Mobile apps dened as a device
FDA regulatory strategy

Design verication and validation

Voluntary standards

FDA guidance

Corrective and Prevent Action Plans

National Institute of Science and Technology Report

Voluntary standards
Recalls:

Service / maintenance / recall.

Implementation strategy

and Collaboration
Updates (FDA vs. non-FDA updates)
Criteria for corrective and preventive action deemed

recalls

Corrections and Removals reporting

Reports of Corrections and Removals

Updates: FDA vs. non-FDA

Reports of adverse events

Predictive analytics

Professional vs. lay use / home use


Labeling: instructions for use and precautions

Lecture 2: Interoperability
Compatibility by design
Hardware
Software

Labeling

Environment of use
FDA regulation of accessories
Federal Communications Commission (FCC)

regulation

Precautions
Instructions for use

Use of Voluntary Standards


Proprietary information
Failure management / follow up
User's vs. manufacturer's legal responsibility

System conguration

Customization

Environment of use

Professional

Home use

www.gcpseminars.com

All rights are reserved GCPSeminars.

seminars
Pricing List

GROUP REGISTRATIONS

Price for One Delegate pass Price: $1,295.00

Send Your Team for Maximum Benet Get your team


up to speed!

Register now and save(Early Bird) $200.(Early Bird) Price

5 Attendees

- Get 10% off

3 to 6 Attendees - Get 20% off


7 to 10 Attendees - Get 25% Off

Register Here

10+ Attendees

- Get 30% off

**Please note the registration will be closed 2 days (48 Hours)


prior to the date of the seminar.

What you get

Payment Options:

1. Learning Objectives

Credit Card: Use the Link to make Payment by

2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.

Visa/Master/American Express card click on the


register now link
Check: Kindly make the check payable to NetZealous

DBA GCPseminars and mailed to 161 Mission Falls


5. Special price on future purchase of web based
trainings.

Lane, Suite 216, Fremont, CA 94539, USA


PO: Please drop an email to

6. Special price on future consulting or expertise


services.
7. Special price on future seminars by GCPseminars.

support@gcpseminars.com or call the our toll free


+1-800-921-1537 for the invoice and you may fax
the PO to 302 288 6884

8. Seminar Kit includes presentation handout, ID card,


brochure, trainings catalog, notepad and pen.

Wire Transfer: Please drop an email to

support@gcpseminars.com or call our toll free


9. Networking with industry's top notch professionals
+1-800-921-1537 for the wire transfer information

Contact Information: Event Coordinator


Toll free: +1-800-921-1537
Fax: 302 288 6884
Email: support@gcpseminars.com

Kindly get in touch with us for


any help or information.
Look forward to meeting you at
the seminar
Team GCPseminars

NetZealous LLC, DBA GCPseminars


161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

www.gcpseminars.com

All rights are reserved GCPSeminars.

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