Lifecycle Process Validation guidance has been published by FDA in 2011 and by PIC/S and EMA in 2015. This guidance reflects ICH guidance on enhanced development and product quality monitoring practices using approaches based on Quality by Design.

The biopharmaceutical industry is adopting lifecycle validation practices incorporating science and risk-based techniques and tools into validation programs. There are some challenges to the adoption of these practices; however, there are also benefits to be gained through enhanced product understanding and process control.
This presentation will provide an overview of the key requirements for lifecycle validation and discuss potential challenges in implementing science and risk-based validation techniques and some practical guidance on how the industry is dealing with implementation.

Learning Objectives:
1) Understanding of the three stages of lifecycle process validation and the activities required in each of these stages
2) Practical guidance that will assist in the preparation and planning for adoption of a lifecycle validation program.
3) Information on the key challenges industry may face and the ISPE resources available to deal with these