Day 01(9:00 AM - 3:00 PM PDT)
- Introduction to the FDA (1 hr)
- 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 (3:30 hr)
- 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 (30 Min)
- The Who, What, Where, When, and Why of CSV
- The Validation Team (30 Min)
- How to select team members
- How to facilitate a validation project
Day 02(9:00 AM - 3:00 PM PDT)
- Ten-Step Process for COTS Risk-Based Computer System Validation (1:30 hr)
- 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 (30 Min)
- Workshop for writing requirements and then expanding them for specifications
- How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
- Software Testing (1 hr)
- 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 (30 Min)
- How to meet the requirements of the EU GDPR
- Purchasing COTS Software (30 Min)
- How to purchase COTS software and evaluate software vendors
- Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
- How to save money
- How to increase quality
- How to increase compliance with less documentation
With an humble beginning in 2004, and a small directed effort, we started our journey to compile the world's first Compliance portal -- complianceonline.com.
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