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2-day In-person Seminar on

Validate your own Excel Spreadsheet Application

Course "Validate your own Excel Spreadsheet Application" has been pre-approved by RAPS as eligible for up to 12 credits

towards a participant's RAC recertification upon full completion.

 

Register Now

Date & Time: July 26th and July 27th 2012

8 AM to 5 PM EDT

Duration: 2 Days

Instructor: David Nettleton

Location: San Francisco

Price : $1495.00

Instructor Profile:

David Nettleton FDA Compliance Specialist

(for one

participant)

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" that 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 185 mission critical software validation projects. ...more

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 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:

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Introductions

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Regulations for Electronic Records 21 CFR Part 11 - Electronic Records & Signatures The Risk-Based Validation Approach Excel Applications - part 1

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Day 2: l l

How to Conduct a Hazard Analysis/Risk Assessment Excel Applications - part 2 ¡ ¡

Create a Hazard Analysis document for your application Create a Testing Protocol document for your application

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Main Concepts to Remember

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Q&A

Areas Covered in the Session: l l l l l

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Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use Excel’s built in 21 CFR Part 11 features. Apply features required for GxP environments without programming macros. Validate your application with minimal documentation. Understand how to use risk assessment to reduce testing and improve productivity. Participate in the workshop as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.

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Your Necessity is our Priority

Create a User Requirements document for your application Create a Project Plan document for your application Create a Functional Specifications document for your application

Learn how to specify and test your application.

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Click here to register for this seminar Who Will Benefit: l

All Excel users

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IT QA, QC

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Laboratory staff Managers, Executives

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Validate your own Excel Spreadsheet Application  

In this two day seminar you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance help...

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