Training Course Syllabus:

How to build and validate Excel spreadsheets for GxP compliance

Course Description:

This two-day seminar teaches how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance. This training event covers all of the required features that have to be configured in Excel. In class you will create the validation documents for an application that you develop. We will use the risk based computer system validation approach that typically saves two thirds of the validation time and costs. This event will make you a better Excel user and help you avoid FDA 483s. The validation approach can be applied to all types of Excel applications and other Commercial Off-The-Shelf applications.

Note: Participants must bring their laptop computer in order to develop and validate an Excel application.

Learning Objective:

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.
Learn how to specify and test your application.

Course Outline:

DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Introductions
Regulations for Electronic Records
Code of Federal Regulations
Court rulings
Guidance documents
21 CFR Part 11 - Compliance for Electronic Records & Signatures
SOPs
Software features
Validation models
Ten-Step Process for Risk-Based Computer System Validation
Requirements
Specifications
Risk assessment
Testing
Excel Application Workshop - part 1
Develop User Requirements validation document for your application
Develop Project Plan validation document for your application
Develop Functional Specifications validation document for your application

DAY TWO (8:30 AM – 4:30 PM)

How to Conduct a Hazard Analysis/Risk Assessment
Hazards
Severity
Probability
Mitigations, impact on testing
Risk Level
Excel Application Workshop - part 2
Develop Hazard Analysis validation document for your application
Develop Testing Protocol validation document for your application
Main Concepts to Remember
Q&A

Seminar Summary:

This two-day seminar teaches how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance. This training event covers all of the required features that have to be configured in Excel.  (see full course description)

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