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:

Jan. 28: http://www.putman.net/newsletter/pme_ifpac08/08/080128.html

Jan. 29: http://www.putman.net/newsletter/pme_ifpac08/08/080129.html

Jan. 30: http://www.putman.net/newsletter/pme_ifpac08/08/080130.html

Video Coverage

FDAs Janet Woodcock on QbD
Emil Ciurczak interviews FDA Deputy Commissioner Dr. Janet Woodcock at IFPAC 2008 in this 10-minute video segment.

NIPTE Executive Director Basu on Why Industry Must Change
Dr. Prabir Basu, director of the National Institute for Pharmaceutical Technology and Education, sees parallels between pharma today and the U.S. automotive industry when Deming called for change. In this 10-minute Q&A, he also discusses NIPTE and its mission.

Jan. 28 Plenary Session: Focus on Physical Properties Needed, Says GSKs Ray Scherzer
Conference chairs Mel Koch, director of CPAC and Moheb Nasr, director of FDAs Office of New Drug Quality Assessment, began the program by discussing the progress that has been made to date in PAT and QbD. Industry appears to be more committed to the concepts, Nasr noted, but a lot of work still needs to be done.

PAT and QbD at DSM
DSM Pharmaceutical's PAT Team members Bir Gujral and C. Freeman Stanfield discuss PAT with Emil Ciurczak in this video.

Duquesne: From Academia to Industry
Duquesne University professors Jim Drennan and Carl Anderson and colleague Steven Short discuss PAT and their consultancy with Emil Ciurczak.

Malverns Neil Lewis Discusses Chemical Imaging
Dr. Neil Lewis, chief technology officer at Malvern Instruments, discusses chemical imaging with Emil Ciurczak on the IFPAC exhibit floor.

NIR and Mammalian Cell Culture Growth: Perspectives from Robert Mattes
Emil Ciurczak reports from IFPAC on mammalian cell culture growth and NIR with Robert Mattes, Applications Scientist at Foss NIRSystems Inc.

PAT Validation and Audits: An Interview with S2Is Bruce Buchanan
In this short video interview, Emil Ciurczak speaks with consultant Dr. Bruce Buchanan of S2I, about PAT validations and audits.

Open Standards for Data Access and Management
In this video, ABB Automation Technology's Thomas Buijis discusses and demonstrates a new OPC-based platform that connects data and allows for direct connection with process control.

IFPAC Audio

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.

Articles

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.

Video: SpectraDri: Moisture Determination for Solid Dose Pharmaceutical Manufacture