Itasca, IL (PRWEB) March 25, 2009
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.
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)