Online Safety Community

21 CFR Part 11 Validation Checklist | Computer Systems Validation

Event Details

21 CFR Part 11 Validation Checklist | Computer Systems Validation

Time: January 25, 2018 at 9am to January 26, 2018 at 6pm
Location: Embassy Suites Boston Logan Airport
Street: 207 Porter St, Boston, MA 02128, USA
City/Town: Boston, MA
Website or Map: http://www.globalcompliancepa…
Phone: 800-447-9407
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Nov 22, 2017

Export to Outlook or iCal (.ics)

Event Description

 

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.

 

Overview:

 

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:

 

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%)*

 

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=901300SEMINAR?safetycommunity-January-2018-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

 

 

Comment Wall

Comment

RSVP for 21 CFR Part 11 Validation Checklist | Computer Systems Validation to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
18 hours ago
Training Doyens posted an event
Thumbnail

Time and Task Management Effectiveness: Working Smarter Every Day at 26468 E Walker Dr, Aurora, Colorado 80016

September 20, 2018 from 1pm to 2:30pm
OVERVIEWTake control of your time...and get control of your entire work day!The speed of everything has changed. Are your time management skills up to the challenge?Do you put off more today than you can ever accomplish tomorrow...exhaust yourself by 4:00 p.m. with only a fraction of your work done...see…See More
20 hours ago
Profile IconBlake Mecham, Nicole Anderson, Tse Kam Hung Danny and 1 more joined Online Safety Community
yesterday
Adam Fleaming posted a blog post

Solid Evidence That Attending Medical Devices Training Is Good for Your Career Development

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products on a daily…See More
yesterday

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service