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32676 Conferences

Process Validation for Biological Products Fitting PV into Process Development and QbD with New Regulations

Added by Referral on 2011-10-13

Conference Dates:

Start Date Start Date: 2011-11-07
Last Date Last Day: 2011-11-07

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

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?
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