Process Validation for Biological Products – Fitting PV into Process Development and QbD with New Regulations 2011
7 November, 2011
Palm Beach FL , Estados Unidos
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.
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?
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.
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?
none
