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2-day In-person Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advance at Washington, DC

Event Details

2-day In-person Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advance at Washington, DC

Time: September 3, 2015 from 9am to 6pm
Location: Washington, DC
City/Town: Washington
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Jun 5, 2015

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Event Description

The Problem:

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.

This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools

The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system

The Seminar:

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:

  1. Validation Master Plan
  2. Complete Validation for a System
  3. Excel Spreadsheet Validation
  4. Change Control
  5. SOPs
  6. Test Tools Validation
  7. Project Management for Validation

Instructor Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. 
Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life sciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality

Date, Time and Venue:

Location: Washington DC

Date: September 3rd and 4th, 2015   

Time: 9am to 6pm

Venue/Hotel: WILL BE ANNOUNCED SOON

 

Ticket Price and Discount:

Price: $1,695.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until July 31, Early Bird Price: $1,695.00

From August 01 to September 01, Regular Price: $1,895.00


Contact Information:

NetZealous LLC, DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Registration Link - http://bit.ly/1IV37Sf

 

 

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