21 CFR 11 Compliance 2014 - 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at SFO, CA

Day 1 ? Agenda
Lecture 1: Introduction / Background
? Introductions / Participants' Understanding
? Participants' Objectives for the Course (Please come prepared to discuss)
Lecture 2: Requirements at a High Level
? Types of Requirements
? Difference between User Requirements & Functional Requirements
Lecture 3: Detailed Requirements Study
? Gathering Requirements
? Entity Relationship Diagram
? Process Decomposition
? Risk Assessment for Requirements
? Exercise on how to create Requirements
Lecture 4: Design
? Design Specifications
? Software Configuration and Build
? Exercise on how to create Design Specifications
Day 2 ? Agenda
Lecture 5: CSV Detailed Study (Cont'd)
? Traceability Matrix
? Verification and Testing
? Exercise Creating Validation Scripts
? Exercise Creating Traceability Matrix
Lecture 6: Other Documents
? Validation Plan
? Test Protocols
o Test Reports
? Validation Report
? Validation Registry
Lecture 7: Special Topics
? Project Management for CSV
? Infrastructure for CSV
? Selecting software for 21 CFR 11 Compliance
? Test Tools for CSV
Lecture 8: Change Control & Business Continuity
? Change Control
? Implementing Business Continuity for CSV