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