The US Food and Drug Administration's Process Validation: General Principles and Practices was finalized over three years ago.
At IVT's Validation Week EU, Dawn Tavalsky led the attendess through an investigation of types of variation found in validation processes. As Tavalsky explained, variation can be classified into either common, or natural, cause and special cause. She further defined and explained process control, capability, process analytical technology, and the US Food and Drug Administration's...
The staff of IVT were onsite at the 2015 EU Validation Week held in the center city of Amsterdam's Crowne Plaza Hotel. Check out some photos from the conference's opening speeches.
The lifecycle approach to process validation has multiple facets that need to be managed to ensure compliance and effective implementation.
At IVT's Validation Week EU, Dawn Tavalsky exlained the sources of variation and methods of control for each stage of the validation process—from process design through the qualification phase and continued process verification. As Tavalsky explained, each stage of validation will have different origins of variation and unique tools for controlling it.