FDA Validation 2011 - Process Validation for Biological Products ? Fitting PV into Process Development and QbD with New Regulations

This Process Validation training for biological products will provide valuable assistance on how to integrate the PV work into your development program using QbD in light of the issuance of new regulations by the FDA.

In this webinar, we will present the regulations governing process validation and its execution and how it is interpreted for biological products, particularly how the new guidance can be implemented to your advantage. We will show how to link together the process development studies and exercises into a compliant process validation program and into batch records that will satisfy the regulators, by investing in a more comprehensive submission by using the elements of Quality by Design.

In addition, the many peripheral studies that are required for biological products will be described. We will outline the common errors that companies make in their program design and illustrate this with real life examples from FDA Warning letters so you will not make the same mistakes yourselves.