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Reduce COTS Software Validation using the risk-based approach
Tuesday, June 19, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
Areas Covered in the Seminar:
- Learn which documents the FDA expects to audit.
- Proven techniques that reduce software costs and implementation times.
- Increase corporate productivity and individual workforce member productivity.
- Efficiently create validation documentation.
- Decrease resource requirements.
- Make documentation more manageable and understandable.
- Avoid 483s and Warning Letters.
- How to implement a computer system to gain maximum productivity.
- Use resources effectively to perform effective validation while avoiding doing too much.
- 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).
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.