Process Validation for Biological Products â€“ Fitting PV into Process Development and QbD with New (FDA Validation)
Venue: Online Event
|Event Date/Time: Nov 07, 2011||End Date/Time: Nov 07, 2011|
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.
Areas Covered in the Seminar:
- Why biological products are more complex than classic drugs and why Process Validation is more of a challenge?
- And understand what the regulations state and how they apply to biologicals?
- How to link together Process Development and Process Validation to yield an effective batch process for your biological?
- How to link together the many validation studies from cell banking to vialing of products?
- What peripheral studies are required by agencies?
- How to use Quality by Design strategies to your advantage in submissions?
- Some of the traps companies fall into developing and executing a Process Validation Program.
- Where companies make costly errors with agencies so you do not have to?