Date: | January 18, 2018 - 9:00am - January 19, 2018 - 6:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | CA, 92101, United States |
Website for Event: | http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901345SE... |
Topic: | Health Education |
Description: | Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Why you should attend: Perhaps your engineering team is beginning its transition to an Agile approach - or perhaps you have a seasoned Agile team and you're just beginning work on FDA-regulated products. You know that risk management is required, but it's not at all clear how you should address it as you go through your backlog grooming, iterations, and end-user demonstrations. The process in ISO 14971 seems "linear" and unsuited to a highly iterative, dynamic lifecycle. How can you fit it into your approach? Areas Covered in the Session: • Software has introduced (or been blamed for) some serious safety hazards Who will benefit: • Project managers Agenda: Day 1 Schedule Lecture 1: Day 2 Schedule Lecture 1: Speaker: Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S. Location: San Diego, CA Date: January 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM Price: Contact us today! NetZealous LLC DBA GlobalCompliancePanel Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=... Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ |
Contact Name: | Event Manager |
Contact Email: | john.robinson@globalcompliancepanel.com |
Contact Phone: | 800-447-9407 |