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!

Forum

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

How to improve safety culture of factories 4 Replies

How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue

Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.

[General Industry] What is your workplace's policy on headphones? Working on one currently. 1 Reply

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson. Last reply by Jen McDade Dec 19, 2018.

Biggest Challenge? 5 Replies

As a distributor of safety supplies, as a webmaster who is trying to sell safety supplies online, one of my main goals is to try to provide value above and beyond just selling supplies and product.So…Continue

Started by Safetyguy08. Last reply by Jen McDade Dec 18, 2018.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service