Manager, Quality Assurance
Data Integrity Training
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.
- 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.
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.