This course discusses the process validation lifecycle activities that are required in preparation for a PPQ campaign and subsequent regulatory filing.  Process validation activities are summarized from initial Quality Target Product Profile (QTPP) development through Continued Process Verification (CPV) plan generation.  When relevant for a particular activity, the training includes multiples strategies which may be used to conform to the applicable regulation. eTraining run time is 2 hr 34 min for 89 slides.  pdf copy and eTraining certificate also included.
 
Highlights of this training include the following:
Learn how to apply a process validation lifecycle approach during the development and commercialization of your product.
Understand the interdependencies of all process validation activities over the process validation lifecycle.
Learn which activities are required prior to the initiation of a process performance qualification campaign, and which are required prior to BLA/NDA filing.
Learn which activities require concurrent validation and understand how to manage them.
Learn valuable right-first-time principles.
 
A Process Validation Lifecycle Management eTool is available to provide best-practice tracking of process validation lifecycle activities.  This eTool also outlines some alternative strategies which can be used during process validation.  Purchase of the eTool plus this eTraining includes a 50% reduction in the cost of a company eTraining license.