- How the regulations help your company to be successful
- Which data and systems are subject to Part 11
- 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
* Includes two 10 minute breaks and a 40 Minute Lunch break
- The Who, What, Where, When, and Why of CSV
- How to select team members
- How to facilitate a validation project
- 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)
* Includes a 10 Minute break
- Workshop for writing requirements and then expanding them for specifications
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
* Includes a 40 Minute Lunch Break
- How to meet the requirements of the EU GDPR
* Includes a 10 minute break
- How to purchase COTS software and evaluate software vendors
- How to save money
- How to increase quality
- How to increase compliance with less documentation