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(1-day curriculum; can be expanded, upon request, to increase number of assessments completed) Ofni Systems can create training materials and on-line help files for all of your software, databases, or computer systems.

Becoming AWS Certified helps individuals gain credibility for their AWS expertise and enables organizations to identify the skilled professionals to lead IT initiatives.

All attendees will receive a Certificate of Training in 21 CFR Part 11, good for satisfying Gx P training requirements.

Ofni Systems has presented informational and training sessions on numerous topics, including Preparing for FDA CSV Inspections, Automating CSV Processes, and 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets.

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(2 hours) Review of Computer System Validation Documentation and Techniques Review the requirements for Computer System validation, 21 CFR 11.10(a).

This course reviews the requirements for computer validation, including the industry-accepted collection of documentation which constitutes a validation package.

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