Introduction to the FDA (1 hr)

21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (3:30 hr)

The Five Keys to COTS Computer System Validation (30 Min)

The Validation Team (30 Min)

Ten-Step Process for COTS Risk-Based Computer System Validation (1:30 hr)

How to Write Requirements and Specifications (30 Min)

How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)

Software Testing (1 hr)

How to write a Data Privacy Statement (30 Min)

Purchasing COTS Software (30 Min)

Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)