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Sale Date Ended
Sale Date Ended
Overview
Lecture 1: Introduction to the FDA
Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
Lecture 3: The Five Keys to COTS Computer System Validation
Lecture 1: Ten-Step Process for COTS Risk-Based Computer System Validation
Lecture 2: How to Write Requirements and Specifications
Lecture 3: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 4: Software Testing
Lecture 5: System Change Control
Lecture 6: Purchasing COTS Software
Lecture 7: Cost Reduction Without Increasing Regulatory or Business Risk