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View Sub-Track: Quality
Thursday, March 27, 2008
C-6: Utilizing Cpk to Understand Pharmaceutical Manufacturing Process Capability 10:15AM - 11:15AM (Thursday, March 27, 2008)
This session will be a discussion of data collection and application of statistical methods to help address the challenges of data starved first-time-quality projects. The foundation of the discussion will be the collection and aggregation of data from a variety of disparate sources including PLC, DCS, SCADA, Alarm & Event and manually entered data. Once the data has been acquired and consolidated a variety of statistical methods can be applied in order to drive enhanced online process visibility. Effectively, the statistical methods produce variables which reflect process capability that can be managed online and viewed like a traditional process variable. By applying analytical tools and product-based Cpk reporting to standard production data, greater process understanding is achieved.
Speaker:
Bart Reitter - Global Industry Manager - Life Sciences, GE Fanuc Intelligent Platforms
C-7: Case Studies in Laboratory Equipment Qualification 2:00PM - 3:00PM (Thursday, March 27, 2008)
This session will present three summaries of equipment qualification projects required by FDA regualtory action and discuss similarities and differences. It will also assess the overall level of compliance and overkill of each of the approaches and discuss how it related to the minimum level of validation expected.
Nancy Tomoney - Senior Validation Scientist, QPharma Corp/CSSC Inc.
Speaker:
Scott Collins - Senior Validation Manager, QPharma Corp/CSSC Inc.
C-8: Formulation and Process Design of Experiments: Quality by Design 3:15PM - 4:15PM (Thursday, March 27, 2008)
The session will provide an understanding of Design of Experiment (DOE) applications with respect to Formulation and Process Development during Drug Product Development. With an understanding of these applications and the data that is generated, companies can ensure predefined product qualtiy from the begining of drug development.
Ryan Doxey - Research Scientist II, Stiefel Research Institute
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