The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: January 25, 2018 at 9am to January 26, 2018 at 6pm
Location: Boston, MA
Street: Embassy Suites Boston Logan Airport
City/Town: 207 Porter St, Boston, MA 02128, USA
Website or Map: http://www.globalcompliancepa…
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Nov 15, 2017
Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Location: Boston, MA Date: January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00
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%)*
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NetZealous LLC DBA GlobalCompliancePanel
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