2-day In-person Seminar on “Validate your own Excel Spreadsheet Application” at Washington DC

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

• 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

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

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Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com/

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