Documenting Software for FDA Submissions 2017

  • 1295.00 Dollar US$
  • Published date: June 15, 2017
    • Washington, DC, Courtyard Arlington Crystal City, United States

Course "Documenting Software for FDA Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto.
The Agile approach helps companies avoid hearing bad news late in a project, by delivering incrementally, integrating regularly, and leaving room for learning as the user stories are refined. In addition, it provides real information on progress and project speed to stakeholders outside the development group.
Documentation under Agile, then, can take advantage of iterative development. Each objection to Agile reveals another point of discipline for effective Agile teams. Requirements can be captured as they are elaborated, and test cases can be firmed up as they are generated during development. For these pieces to fit together, quality processes need to be flexible.
Even clearer is the case for hazard analysis - it and Agile are made for each other. Just as requirements are refined in the course of a project, so too does the knowledge of hazards and design of their mitigations. Risk management, therefore, can and should be included in iteration tasks.
We are coming to see that Agile methods not only result in acceptable medical device development, but lead to much better outcomes. IEC 62304 does not specify any lifecycle model (and states as much); documentation can therefore grow out of iterative activities


Location: Washington, DC Date: August 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA

Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until June 30, Early Bird Price: $1,295.00 From July 01 to August 08, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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=901070SEMINAR?science-marketplace-August-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

  • Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    Training and Teaching Philadelphia, PA ( Philadelphia, PA) November 9, 2017 1295.00 Dollar US$

    Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete im...

  • Product Reliability Training Courses | Product Reliability Testing

    Product Reliability Training Courses | Product Reliability Testing

    Training and Teaching Detroit, MI ( Detroit, MI) November 9, 2017 1295.00 Dollar US$

    Course "Predicting & Improving Product Reliability" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Although a primary objective of reliability analysis is...

  • Internal Audit Checklist for Medical Devices | Quality Audit

    Internal Audit Checklist for Medical Devices | Quality Audit

    Training and Teaching Washington, DC ( Washington, DC) November 9, 2017 1295.00 Dollar US$

    Course "Quality Audits for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Quality audits are an important element in implementing...