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DataIntegrity_BR
Dana Tye, ASQ CQA
Manager, Quality Assurance
Kymanox

Data Integrity Training

Comprehensive Training Presentation, Accompanying Quiz and Answer Key, and Supporting Training Documents
Product Description

This package also comes as a part of our CGMP Starter Kit.

This package offers training on the basic principles of data integrity, including real case studies.

Topics include:

  • Types of data
  • Data transcription
  • 21 CFR Part 11 compliance

The presentation also includes the a examples of data integrity related observations in FDA Form-483s and Warning Letters. Purchase of this package includes an optional 30 minute consulting conversation with a qualified subject matter expert. 

Includes:   Free Pro
Purchase Price   $0 $199
Short Summary Presentation (4 slides) PDF yes yes
Training Presentation (34 slides) Powerpoint no yes
Editable Training Presentation (34 slides) Powerpoint no yes
Attendance Sheet Template (1 page) Word no yes
Quiz with Answer Key (4 pages) Word no yes
Editable Quiz with Answer Key (4 pages) Word no yes
Optional 30 Minute Consultation with Subject Matter Expert (SME) Consultation no yes
Purchase  
Return on Your Investment

Kymanox estimates that it would take a qualified contractor 24 hours (16+8) to complete the work included in this package.

This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.

Please use the calculator at right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.

Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $40/hour for a qualified contractor.

Available Hours Per Day refers to the number of hours a single resource has to work on the project per day.  8 hours assumes that the resource is fully dedicated to the project.

   
   
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