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2day Inperson Seminar on Validate your own Excel Spreadsheet Application at Washington DC

6/27/2013 9:00 AM - 6/28/2013 6:00 PM


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

• Create a User Requirements document for your application

• Create a Project Plan document for your application

• Create a Functional Specifications document for your application

Day 2 - 28th June 2013

Lecture 6: How to Conduct a Hazard Analysis/Risk Assessment

Lecture 7: Excel Applications - part 2

• Create a Hazard Analysis document for your application

• Create a Testing Protocol document for your application

Lecture 8: Main Concepts to Remember

Lecture 9: Q&A

Who Will Benefit:

All Excel users



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.


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





NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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