2009 Webcast Schedule
We are proud to invite you to participate in the PharmaManufacturing.com and PharmQbD.com 2009 Webcast Series. In 2009 we will be hosting eight webcasts on a range of pressing pharmaceutical industry topics. These webcasts will feature thought-leaders from the pharmaceutical industry, regulatory officials when appropriate, consultants and other leading pharmaceutical industry experts.
Below are program summary descriptions for the next four webcasts.
To register, please click on any of the titles.
If you have questions, comments or concerns, please don't hesitate to contact Tonia Becker, Publisher, at 630-467-1301 ext 455, tbecker@putman.net.
Broadcast Date: June 4, 2009 at 11AM EDT
LEAN and Six Sigma: Sustaining Gains Throughout the Product Lifecycle
Many pharmaceutical and biopharma companies have announced bold Lean Six Sigma programs, only to have them quietly disappear a few years later. Sustainable results offer huge payoffs, but require management support, corporate commitment and nurturing from the R&D stage through manufacturing. Here, companies that are in Lean Six Sigma for the long haul share best practices and the financial results that you can expect. They also address how to get management buyin for programs that will withstand the test of time.
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Biopharmaceutical Manufacturing Gears Up for 2020
Type: On-Demand Webcast
Biopharmaceutical Manufacturing Gears Up for 2020 As biopharmaceuticals development and manufacturing become more important, new challenges in up- and down-stream processing, manufacturing, analytics and process control must be met and overcome. This webcast will focus on key issues for the industry including manufacturing operations, analytics, process control and Lean and Six Sigma.
Speakers:
Downstream Processing Plays Catch-up – Eric Langer, Managing Partner, Bioplan Associates
Optimizing Scaleup – Brian Stamper, Sr. Manufacturing Associate, Eli Lilly
Process Control and Optimization – Trish Benton, Life Sciences Consultant, Broadley-James
Process Development: Data Management – Oscar Lara-Velasco, GSK
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Redefining Pharmaceutical Process Validation
Type: On-Demand Webcast
FDA's new process validation guidance spells out the new rules for process validation. In this live webcast, FDA enforcement chief Joe Famulare talks about the guidance, while Jim Agalloco spells out what it means for manufacturers, specifically for sterile processing; Bikash Chatterjee of Pharmatech outlines how to apply a Six Sigma approach to validation, while NNE-Pharmaplan's Line Lundsberg-Nielsen discusses how to apply new principles to improve a legacy product.
Presenters
Joe Famulare on Process Validation and Key Areas Leading to 483's
Bikash Chatterjee on Building and Tailoring a Lean Six Sigma Approch for Validation Processes
Line Lundsberg-Nielsen will discuss the impact of FDA's Proposed Process Validation Guidance on Quality by Design for Legacy Products
Jim Agalloco on FDA's Process Validation Guidance and Its Impact on Aseptic Processing
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Pharma Traceability in the Real World: The Bottom-Line Benefits of Track and Trace Content
Type: On-Demand Webcast
Avoiding compliance problems and increasing patient safety are very compelling reasons for implementing traceability. However, there are strong commercial reasons for acting soon to develop a strategy and invest in the technology required: improving supply chain efficiencies and gaining an edge in the market.
In a webcast aired on March 12 by PharmaManufacturing.com, these points were addressed by experts including a participant in the BRIDGE pharma traceability project, part of a broad traceability project that involved generic pharmaceutical manufacturers, packagers, wholesalers, warehouse operations, and hospitals in Europe.
The goal of this project was to demonstrate the feasibility of implementing track and trace technology from the drug manufacturing plant to the hospital pharmacy. John Clark, commercial director of the generic drug manufacturer Athlone Laboratories, discussed some of the technical challenges that the project involved, as well as the benefits. Joining him were Henri Barthel, director of partnerships with GS1, colleague Jan Deneker, as well as Aberdeen Group senior analyst Matthew Littlefield, who presented data suggesting that drug manufacturers have been improving key supply chain performance metrics because of their traceability and compliance initiatives.
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