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Event Details

Summary of the Workshop:

In this two-day seminar you will learn how to configure Excel applications with the features required for 21 CFR Part 11 thereby 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 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 and other Commercial Off-The-Shelf (COTS) validation projects.

Participants must bring their laptop and an Excel application to validate. To get full benefit of this workshop it is best to come with a colleague so you can be your own project team.


All Excel users



Laboratory staff




Meet your Expert:

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 240 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

RAC Credits: 12

Date: October 2nd & 3rd, 2014

Event Details:

Location: Atlantic City, NJ

Venue: Will Be Announced Soon

Registration: Open Enrollment

Delivery: Face-to-Face event

Price: $1,295.00

Until September 12, Early Bird Price: $1,295.00

From September 13 to September 30, Regular Price: $1,495.00


Learning Objectives:

Introduction to the Excel Spreadsheet

 Learn Regulations for Electronic Records

Learn 21 CFR Part 11 - Electronic Records & Signatures

Ten Step Process for Risk-Based Computer System Validation

Learn Excel Applications and how to create a User Requirements, Project Plan and Functional Specifications

How to Conduct a Hazard Analysis/Risk Assessment

Excel Applications and how to create Hazard Analysis and Testing Protocol document for your application

Course Web Site:

Organizer: GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Our Achievements:

Over 300 Experts that are Renowned in their Respective Areas

Successfully Trained more than 20,000 Compliance Professionals

A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth

Having more than 2000 Online Courses

Successfully Completed more than 170 Seminars in US and Globally




                John Robinson

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

                Phone: 1800-447-9407

                Fax: 302-288-6884



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Will Be Announced Soon
Copenhagen, CA 1001