Free Webcast: Redefining Pharmaceutical Process Validation

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FDA's new guidance requires that manufacturers take a new, more flexible approach to process validation. In this program, experts discuss the opportunities presented by the guidance, how they differ from traditional approaches and what it all means for technology investment, plant debottlenecking, improving existing operations and validating and commissioning new plants.

For pharmaceutical manufacturers, the FDA's new guidance spells out clearly a new philosophy toward process validation that is rooted in process understanding, and allows more flexibility. In this program from Pharmaceutical Manufacturing magazine, experts discuss the opportunities presented by the guidance, how they differ from traditional approaches and what it all means for technology investment, plant debottlenecking, improving existing operations and validating and commissioning new plants.

Presenters include:

Joe Famulare, Director, Office of Compliance, FDA Speaking on Process Validation and Key Areas Leading to 483's

Line Lundsberg-Nielson of NNE Pharmaplan will discuss the impact of FDA's proposed Process Validation Guidance on Quality by Design for Legacy Products

Jim Agalloco, Agalloco Associates, Speaking on FDA's Process Validtion Guidance and Its Impact on Aseptic Processing

Bikash Chatterjee, Pharmatech Associates, Speaking on Tailoring a Lean Six Sigma Approach for Validation Processes

The webcast, sponsored by Bruker and Malvern Instruments, will take place Thursday, March 26, at 11:00 AM ET/10:00 AM CT/9:00 AM PT/16:00 GMT.

Visit the following link to register for the event: http://www.putman.net/webcast/phm/09/090320.html

You may also register for other upcoming webcasts:

Biopharmaceutical Manufacturing Gears Up for 2020 (April 23, 2009)
LEAN and Six Sigma: Sustaining Gains Throughout the Product Lifecycle (June 4, 2009)

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