MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at SFO, CA

Event Details

2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at SFO, CA

Time: July 24, 2014 at 9am to July 25, 2014 at 6pm
Location: WILL BE ANNOUNCED SOON
Street: SFO, CA
City/Town: San Francisco
Website or Map: http://bit.ly/1g4FCsK
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: May 23, 2014

Export to Outlook or iCal (.ics)

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 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

About Speaker:

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley 

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. 

DATE, VENUE & PRICE:

Location: SFO, CA   Date: July 24th & 25th, 2014     Time: 9 AM to 6 PM EDT 

VenueWILL BE ANNOUNCED SOON

Price$1,295.00

 

Discount:

 

Register now and save $200. (Early Bird)
Until July 15, Early Bird Price: $1,295.00

From July 16 to September 09, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

EVENT Link – http://bit.ly/1g4FCsK

LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

NetZealous LLC, 
DBA GlobalCompliancePanel, 
161 Mission Falls Lane, 
Suite 216, Fremont, CA 94539, USA 
Phone: 1800 447 9407

Comment Wall

Comment

RSVP for 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at SFO, CA to add comments!

Join MedTech I.Q.

Attending (1)

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service