Tenth SCC Meeting
Date: Jan 06, 2013 11:00 pm – Jan 07, 2013 11:00 pm
The next Software Certification Consortium's (SCC) meeting will be an open, public workshop on January 7 and 8 in Silver Spring Maryland at the offices of the Food and Drug Administration.
There is no charge for attending the SCC meeting. Lunches, breakfasts and coffees/teas are provided, but registration is required. To register please fill out the registration form and e-mail it to me at pauljoannou@rogers.com
If you are not a US citizen, then you need to also send me a foreign visitor data request form by December 18. This is required since we are holding the workshop at FDA facilities.
The focus of the meeting will be to define "Evidence Required For Highest Integrity Level Systems".
The agenda has a mix of presentations and breakout sessions focused on:
· Evidence that the system requirements are correct, complete and understandable
· Evidence that the implementation meets its requirements
· Evidence that the operational and maintenance requirements and constraints are identified correctly and satisfied
A fourth breakout session will focus on determining the highest priority work required to address issues identified in the first three breakout sessions where there is not a strong basis for consensus for the required evidence.
For those that will be unable to attend in person, we will be webcasting the workshop using WebEx. . If you would like to attend via WebEx please register for each day at
https://mcmaster-events.webex.com/mcmaster-events/onstage/g.php?t=a&d=666111658 for the Monday session
https://mcmaster-events.webex.com/mcmaster-events/onstage/g.php?t=a&d=665157591 for the Tuesday session
After registering, an e-mail will be sent to you with a link that you can use to join the event.
We have arranged for a discounted rate at the Courtyard Silver Spring North hotel. You can make a reservation online using this link, or call them directly at 1 888 236 2427 and ask for the SCC Workshop Room Block at the Courtyard Silver Spring North. The discounted rooms are only being held until Dec 20 so please book by then.
The current agenda for the SCC meeting is here.
Directions to get to the FDA facilities are as follows.
The address of the FDA campus is 10903 New Hampshire Avenue, Silver Spring, MD 20993.
If you are taking a taxi the directions are:
When one turns off New Hampshire Ave into the FDA campus Main entrance there is a traffic circle at the end of the drive.
If the traffic circle wasn’t there the drive would end at Bldg 02.
Folks should enter Bldg 02 at this “security checkpoint”.
At this security checkpoint, they should ask for or wait for an escort to bring them to the conference room.
Folks driving should park in the northern visitor lot and then walk to Bldg 22. (yes that’s 22 not 02 - although you are free to walk to bldg. 02 if you can find it on your own …)
Directions to this visitor parking lot are as follows:
Assuming you are at the intersection of 495 beltway and New Hampshire Ave… (top of the DC beltway)
Go North on New Hampshire Ave about 1.5 miles.
There will be 2 entrances to the FDA campus on the right.
Go past the 1st entrance and turn right into the second entrance (Traffic light here says “Northwestern” on it pointing in the opposite direction)
When you get to the guard house take an immediate right, (next to the truck inspection station) and go up a little hill which is a visitor parking area.
From that parking area you will see a gray cement parking structure.
Walk alongside the parking structure to the end of the drive (see flags).
There will be several flags at the end of the drive in front of what is called Bldg 22.
Enter this bldg and ask the security folks to contact someone to escort you to the conference rooms.
We look forward to seeing you there. If you have any questions or have any trouble accessing the forms please do not hesitate to contact me.
Best regards,
Paul Joannou
Submitted by Paul Joannou
on
The next Software Certification Consortium's (SCC) meeting will be an open, public workshop on January 7 and 8 in Silver Spring Maryland at the offices of the Food and Drug Administration.
There is no charge for attending the SCC meeting. Lunches, breakfasts and coffees/teas are provided, but registration is required. To register please fill out the registration form and e-mail it to me at pauljoannou@rogers.com
If you are not a US citizen, then you need to also send me a foreign visitor data request form by December 18. This is required since we are holding the workshop at FDA facilities.
The focus of the meeting will be to define "Evidence Required For Highest Integrity Level Systems".
The agenda has a mix of presentations and breakout sessions focused on:
· Evidence that the system requirements are correct, complete and understandable
· Evidence that the implementation meets its requirements
· Evidence that the operational and maintenance requirements and constraints are identified correctly and satisfied
A fourth breakout session will focus on determining the highest priority work required to address issues identified in the first three breakout sessions where there is not a strong basis for consensus for the required evidence.
For those that will be unable to attend in person, we will be webcasting the workshop using WebEx. . If you would like to attend via WebEx please register for each day at
https://mcmaster-events.webex.com/mcmaster-events/onstage/g.php?t=a&d=666111658 for the Monday session
https://mcmaster-events.webex.com/mcmaster-events/onstage/g.php?t=a&d=665157591 for the Tuesday session
After registering, an e-mail will be sent to you with a link that you can use to join the event.
We have arranged for a discounted rate at the Courtyard Silver Spring North hotel. You can make a reservation online using this link, or call them directly at 1 888 236 2427 and ask for the SCC Workshop Room Block at the Courtyard Silver Spring North. The discounted rooms are only being held until Dec 20 so please book by then.
The current agenda for the SCC meeting is here.
Directions to get to the FDA facilities are as follows.
The address of the FDA campus is 10903 New Hampshire Avenue, Silver Spring, MD 20993.
If you are taking a taxi the directions are:
When one turns off New Hampshire Ave into the FDA campus Main entrance there is a traffic circle at the end of the drive.
If the traffic circle wasn’t there the drive would end at Bldg 02.
Folks should enter Bldg 02 at this “security checkpoint”.
At this security checkpoint, they should ask for or wait for an escort to bring them to the conference room.
Folks driving should park in the northern visitor lot and then walk to Bldg 22. (yes that’s 22 not 02 - although you are free to walk to bldg. 02 if you can find it on your own …)
Directions to this visitor parking lot are as follows:
Assuming you are at the intersection of 495 beltway and New Hampshire Ave… (top of the DC beltway)
Go North on New Hampshire Ave about 1.5 miles.
There will be 2 entrances to the FDA campus on the right.
Go past the 1st entrance and turn right into the second entrance (Traffic light here says “Northwestern” on it pointing in the opposite direction)
When you get to the guard house take an immediate right, (next to the truck inspection station) and go up a little hill which is a visitor parking area.
From that parking area you will see a gray cement parking structure.
Walk alongside the parking structure to the end of the drive (see flags).
There will be several flags at the end of the drive in front of what is called Bldg 22.
Enter this bldg and ask the security folks to contact someone to escort you to the conference rooms.
We look forward to seeing you there. If you have any questions or have any trouble accessing the forms please do not hesitate to contact me.
Best regards,
Paul Joannou