The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 27, 2013 at 9am to June 28, 2013 at 6pm
Location: Courtyard Washington Capitol Hill/Navy Yard
Street: 140 L Street SE
City/Town: Washington, District Of Columbia 20003 USA
Website or Map: http://bit.ly/17J1Gkt
Phone: 800-447-9407
Event Type: conference
Organized By: John Robinson
Latest Activity: May 27, 2013
Overview:
In this two-day seminar, you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance, helping you to avoid 483s. Using the risk-based computer system validation approach, you will validate your own Excel application. Use of the validation templates is necessary and important because it typically saves two-thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application validation projects.
Course Outline:
Day 1 - 27th June 2013
Lecture 1: Introductions
Lecture 2: Regulations for Electronic Records
Lecture 3: 21 CFR Part 11 - Electronic Records & Signatures
Lecture 4: The Risk-Based Validation Approach
Lecture 5: Excel Applications - part 1
Day 2 - 28th June 2013
Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment
Lecture 7: Excel Applications - part 2
Lecture 8: Main Concepts to Remember
Lecture 9: Q&A
Who Will Benefit:
All Excel users
IT
QA, QC
Laboratory staff
Managers, Executives
About Speaker:
David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.
He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects.
DATE, VENUE & PRICE:
Location: Washington DC | June 27th & 28th, 2013 | 9 AM to 6 PM EDT
Venue: Courtyard Washington Capitol Hill/Navy Yard
Price: $1,295.00
Register now and save $200. (Early Bird)
Until March 29, Early Bird Price: $1,295.00
From March 30 to June 25, Regular Price: $1,495.00
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php
GlobalCompliancePanel
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43337 Livermore Common, Fremont CA 94539, USA
Click Here: http://bit.ly/17J1Gkt
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