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.