Seminar on Software Risk Management in Philadelphia

Start Date : September 24, 2018
End Date : September 25, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : globalcompliancepanel@gmail.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Website

Description



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


Description:


The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.




Why you should attend:


Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.




Who Will Benefit:



Agenda:


Day 1 Schedule




Lecture 1 (90 Mins):


Legal and regulatory requirements for risk management


Risk management and quality systems




Lecture 2 (90 Mins):


Risk Management Basics





Lecture 3 (90 Mins):


Software failures





Lecture 4 (90 Mins):


System Architectures


Software Architecture


Software Tools and Methods


Multiprocessor systems


Real-time challenges


 


Day 2 Schedule




Lecture 1 (90 Mins):


Software Criticality Classification





Lecture 2 (90 Mins):


The 62304 Development Process



Comparison to FDA requirements




Lecture 3 (90 Mins):


Software Risk Management


Software Configuration Management


Software Problem Resolution


Software Maintenance




Lecture 4 (90 Mins):


Legacy Software


Risk-based verification


Third-party software (SOUP, COTS)


Speaker:


Markus Weber


Principal Consultant, System Safety Inc. 



Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.


Location:  Philadelphia, PA Date: September 24th & 25th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153


Price:


Price: $1,495.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*


Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Sponsorship Program benefits for seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901822SEMINAR?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


 


 


 




v\:* {behavior:url(#default#VML);}
o\:* {behavior:url(#default#VML);}
w\:* {behavior:url(#default#VML);}
.shape {behavior:url(#default#VML);}







Normal
0




false
false
false

EN-US
X-NONE
X-NONE




















































































































































































































































































































































































































/* Style Definitions */
table.MsoNormalTable
{mso-style-name:"Table Normal";
mso-tstyle-rowband-size:0;
mso-tstyle-colband-size:0;
mso-style-noshow:yes;
mso-style-priority:99;
mso-style-parent:"";
mso-padding-alt:0cm 5.4pt 0cm 5.4pt;
mso-para-margin-top:0cm;
mso-para-margin-right:0cm;
mso-para-margin-bottom:8.0pt;
mso-para-margin-left:0cm;
line-height:107%;
mso-pagination:widow-orphan;
font-size:11.0pt;
font-family:"Calibri",sans-serif;
mso-ascii-font-family:Calibri;
mso-ascii-theme-font:minor-latin;
mso-hansi-font-family:Calibri;
mso-hansi-theme-font:minor-latin;
mso-ansi-language:EN-US;
mso-fareast-language:EN-US;}

Registration Info


Cost : $1,495.00

Event link :  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901822SEMINAR?meetings4docs-sep-seo
 

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel 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.

Tel: 800-447-9407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Health & Nutrition.




Your Review

You must be logged in to post a comment.