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

  • Risk Based Incident Management and [CAPA for GxP] Operations

    Risk Based Incident Management and [CAPA for GxP] Operations

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant pr...

  • Things To Do Immediately About Master Validation Plan 2019

    Things To Do Immediately About Master Validation Plan 2019

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: How to develop or improve upon a Master Verification and Validation Plan and System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements. Why should you Attend: The billions of dollars spent by industry annual...

  • Take Advantage Of 21 Cfr Part 11 - Read [Immediately] These Tips

    Take Advantage Of 21 Cfr Part 11 - Read [Immediately] These Tips

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. Why should you Attend: CSV enables the level and r...