2-Day Virtual Seminar on Risk-based Computer System Validation: Reduce Costs and Avoid 483s

12 hours over 2 days
9am to 3pm Pacific each day
10:20-10:30 break
12:00-12:40 lunch
1:50-2:00 break

Day 1 (two 10 min breaks, 40 min lunch, 5:00 instruction, 6:00 total for day 1)

• Introduction to the FDA (1:00) {1:00}
  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11
• 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (3:00) {4:00}
  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents
• The Five Keys to COTS Computer System Validation (0:30) {4:30}
  
  • The Who, What, Where, When, and Why of CSV
    
• The Validation Team (0:30) {5:00}
  
  • How to select team members
    
  • How to facilitate a validation project
    

Day 2 (two 10 min breaks, 40 min lunch, 5:00 instruction, 6:00 total for day 2)

• Ten-Step Process for COTS Risk-Based Computer System Validation (1:30) {1:30}
  
  • Learn which documents the FDA expects to audit
    
  • How to use the risk-based validation approach to lower costs
    
  • How to link requirements, specifications, risk management, and testing
    
  • Document a computer system validation project using easy to understand fill-in-the-blank templates
    
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
    
• How to Write Requirements and Specifications (0:30) {2:00}
  
  • Workshop for writing requirements and then expanding them for specifications
    
• How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:30}
  
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
    
• Software Testing (0:30) {3:00}
  
  • Reduce testing by writing test cases that trace to elements of risk management
    
  • How to write efficient test cases
    
• How to write a Data Privacy Statement (0:30) {3:30}
  
  • How to meet the requirements of the EU GDPR
    
• Purchasing COTS Software (0:30) {4:00}
  
  • How to purchase COTS software and evaluate software vendors
    
• Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}
  
  • How to save money
    
  • How to increase quality
    
  • How to increase compliance with less documentation