In 1987, the US Food and Drug Administration (FDA) released General Principles of Process Validation (PV), the first-ever guidance standard on process validation in the life sciences field. That document spawned many other more specific standards published by governments and industries. Modern standards and even competing guidances put out by individual FDA divisions such as General Principles of Software Validation (CDRH) and Validation of Cleaning Practices (CDER) all incorporate modern techniques and risk-based methodologies that simply did not exist in 1987.
In 2011, FDA finalized its Process Validation: General Principles and Practices, which obsoleted the 1987 guidance and moved directly to the forefront of modern validation theory. Meanwhile, the FDA’s Medical Device division needed a more modern standard to support the PV requirement built into the Quality System regulations, and had adopted the European SG3 Process Validation standard.
This course will give you the information you must have to comply with domestic and international Process Validation requirements. By attending this interactive, 90-minute session, you will:
- Understand what the various guidances call for, and help you “filter through the noise” so you can focus on critical aspects rather than wasting time and money
- Be able to develop a Process Validation plan that will ensure compliance
- Ensure that root cause analysis, corrective and preventative actions, and continuous improvement are all part of your culture
Finally, this presentation will explain the new guidance, highlight what is different from the old standard (nearly everything!), and discuss the principles underlying the new CDER thinking.