IFPAC 2008 SHOW COVERAGE
2008 IFPAC Conference
The IFPAC conference is being held concurrently with the 16th Intl. OnSite Analysis Conference. The three-day forum focuses on the latest developments in Process Analytical Technology: emerging techniques, new applications, instrumentation, software, standards, and a look into the future. Topics include: separation techniques; FTIR, Near IR, UV/VIS; Raman spectroscopy/lasers/NMR/LIBS; mass spectroscopy; control and data acquisition; micro/nano technologies; technology transfer and training; process sampling, characterization, understanding, control and quality; and Pharmaceutical Design Space and Quality by Design, among others.
PharmaManufacturing E-News Show Dailies:
- Audio Interview: FDA Progress Report and QbD Update
Emil Ciurczak speaks with Moheb Nasr, director of FDA's Office of Drug Quality, on developments at the Agency and Quality by Design (QbD).
- Lundberg-Nielsen on How to Use QbD with Legacy Products
In this audio interview, Emil Ciurczak talks with Line Lundsberg-Nielsen, a consultant at NNE Pharmaplan (Surrey, UK) about applying Quality by Design principles to legacy products.
- FDAs Famulare: ICH Q-10 to Crystallize PATs Benefits
In a pre-conference session on Sunday, representatives from industry and FDA met to discuss QbD and how to overcome obstacles in making it part of pharmas fabric.
- Quality by Design in the Design Space
If discussions of the Design Space seem too theoretical, IFPACs Monday session on QbD provided some views from the trenches, and examples from Novartis and Merck.
- Quality by Re-Design or Reverse QbD?
If the whole concept of QbD seems to leave out manufacturing, Line Lundsberg-Nielsen of NNE Pharmaplan discussed ways one can re-engineer and improve legacy products and revalidate them. She compares it to an archaeological dig, but it can, and often should, be done.
- The Human Element and Process Analyzers
Walter Henslee, former Dow scientist and editor of JPAC, IFPACs technical journal, discussed challenges and benefits of optimizing analyzer operation.