FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use 2017

  • 1295.00 Dollar US$
  • Published date: October 23, 2017
    • San Diego, CA, San Diego, CA, United States

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice.
The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, and the explosion in the use of wireless communication and mobile apps.
Inadequate cybersecurity programs and the lack of interoperability for healthcare users pose the greatest threat to any healthcare system. Software exploitations are using more sophisticated approaches and the hackers' programs are readily available on the "dark web."
The increasing sophistication required to protect software programs and have them work with other programs requires progressive software design and software validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. FDA can ask you what you have considered before you take a product to market. Whether your software can survive unscathed is another question. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems, preventing them from recurring. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful of the unknowns that lurk in the future of software regulated as a device by the FDA.




Location: Boston, MA Date: December 7th & 8th, 2017 and Time: 9:00 AM to 4:30 PM
Venue: Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA

Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until October 20, Early Bird Price: $1,295.00 From October 21 to December 05, Regular Price: $1,495.00



Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901294SEMINAR?science-marketplace-December-2017-SEO
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Products Used in Early Phase IND Studies

    Products Used in Early Phase IND Studies

    Quality Control, Safety & Security Fremont (California) November 27, 2017 Free

    Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages ...

  • Clinical Data Systems Regulated by FDA

    Clinical Data Systems Regulated by FDA

    Quality Control, Safety & Security Fremont (California) November 27, 2017 Free

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regul...

  • HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

    HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

    Quality Control, Safety & Security San Diego, CA ( San Diego, CA) October 23, 2017 1295.00 Dollar US$

    Overview: HIPAA Rules are easy to follow, step-by-step, once you know the steps. In this seminar Paul Hales will capture your attention with visual presentations, exercises and discussion that explain HIPAA compliance in plain language. And he will s...