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ASQ's Don Singer on Pharma's Evolving Quality Systems
In this audio interview, Don Singer, a Malcolm Baldrige National Quality Award Examiner and ASQ national director, certified specialist microbiologist and Six Sigma Green Belt discusses pharma's progress along the road to continuous quality improvement. Could a pharma company win the Baldrige Prize one day? Perhaps, but as Singer says, the journey is far more important than the destination. Benchmarking and connecting with experts from other industries, and adopting their best practices, is critical.
PharmaManufacturing.com
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ASQ's Don Singer on Pharma's Evolving Quality Systems
04/02/2008
In this audio interview, Don Singer, a Malcolm Baldrige National Quality Award Examiner and ASQ national director, certified specialist microbiologist and Six Sigma Green Belt discusses pharma's progress along the road to continuous quality improvement. Could a pharma company win the Baldrige Prize one day? Perhaps, but as Singer says, the journey is far more important than the destination. Benchmarking and connecting with experts from other industries, and adopting their best practices, is critical.
Analytical Instrumentation Qualification in a PAT/QbD World
03/14/2008
Cadrai partners John E. Carroll and Emil W. Ciurczak discuss integrating instruments and process sensors for PAT/QbD applications in this PAT course module.
Leveraging Real-time Demand Signals to Improve Operational Performance
03/12/2008
In pharma, everyone knows that what gets prescribed doesn’t match what gets shipped from the factory. Leading companies are using a combination of improved demand sensing and increased supply chain agility to improve operational performance. Learn how you can improve your company’s product availability while reducing inventory by leveraging recent developments in channel data and technology in this podcast by Edge Dynamics.
Rick Cooley on LC and Life After Lilly
02/14/2008
Rick Cooley, a PAT expert and leader of Dionex’s Center of
Excellence, discusses online chromatography method
development with Contributing Editor Emil Ciurczak.
“PAT Talk” with Jack Carroll and Emil Ciurczak
02/13/2008
In this pilot, taped at IFPAC, Cadrai partners Jack Carroll
and Emil Ciurczak talk about PAT, QbD, and process analytics.
Soon we’ll be moving to an interactive, call-in format for
this program, and featuring it monthly.
Podcast: Trace the Truth of Pharmaceutical Anti-Counterfeiting
10/08/2007
In this podcast, Editor in Chief Agnes Shanley interviews Dr. Cedric Loiret-Bernal, CEO of Chicago-based NanoInk, Inc. about the promise his company’s nano-encryption technology holds for the pharmaceutical industry.
Podcast: Behind the Curtain at the AAPS Stability Testing Workshop
10/04/2007
Contributing Editor Emil Ciurczak interviews Saji Thomas, associate director for QC operations at Par Pharmaceuticals and the driving force behind the development of this workshop. They discuss the industry trends and conditions that necessitated such a workshop, and how Thomas secured buy-in from industry groups including AAPS, EAS, PhRMA, GPhA and CHP
Podcast: Wyeth’s PAT Progress in Puerto Rico
10/04/2007
Emil Ciurczak interviews Pedro Hernández-Abad, principal PAT specialist II at Wyeth’s Guaynabo, Puerto Rico facility, about how far the company’s PAT program has come since it began four years ago, and how the Guaynabo plant and the Pearl River (N.Y.) plant collaborate on PAT.
Mark McClellan on Pharma’s Role in U.S. Health Care System
09/25/2007
Speaking at a Sept. 19 conference at Glatt Pharmaceutical Services, former FDA Commissioner Mark McClellan reminded pharma manufacturing professionals why their work is a critical part of the national health care debate.
Podcast: Innovation vs. Efficiency
08/23/2007
Six Sigma leader and consultant Peter Pande responds to the ongoing debate on Six Sigma vs. Innovation.
Podcast: Generic Biologics
07/05/2007
A Senate committee has approved legislation to create an FDA regulatory pathway for generic biologics. Mary Agnes Carey, associate editor of CQ HealthBeat, comments on this recent activity.
Sandoz' Ajaz Hussain Addresses IFPAC 2007
02/08/2007
In this excerpt from his introductory remarks at IFPAC 2007, Dr. Hussain, former deputy director of FDA's CDER's Office of Pharmaceutical Sciences and a leader of the PAT movement, discussed the need to redefine specifications and quality to allow for continuous improvement.
Ram Sasisekharen on Systems Biology and Standardization
02/07/2007
In his plenary speech at IFPAC 2007, Dr. Ram Sasisekharen of MIT, a specialist in glycoengineering, discussed the need for standardization in techniques used for characterization, process understanding, and clinical trials. The technology already exists, he says, but must be used wisely.
USP's Gary Ritchie with an Update on PAT Standards Development
02/06/2007
Emil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP. Listen to the interview or read the transcript here.
Ciurczak Interviews Nasr on QbD and the Need for Robust Processes
02/06/2007
In this interview with Emil Ciurczak during IFPAC 2007, Dr. Nasr discusses Agency activities and challenges, and what we might see in the future.
Dr. Moheb Nasr's IFPAC Plenary Speech
02/06/2007
Here we provide a transcript and a two-part audio file of Dr. Nasr's keynote address at IFPAC 2007, in which he emphasized FDA's continued interest in PAT and its importance in a Quality by Design framework.
FDA's Chris Watts on New Directions for PAT at FDA
02/06/2007
In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.
CPAC's Mel Koch on Future Frontiers for Pharmaceutical PAT
02/06/2007
FDA's Janet Woodcock on PAT and The Critical Path
02/06/2007
In her keynote address at IFPAC 2007, FDA's Chief Medical Officer, Dr. Janet Woodcock, discussed the Critical Path Initiative, and PAT's role in improving the overall drug development and manufacturing process.
MIT's Dr. Ram Sasisekharen discusses PAT and Biopharma
02/04/2007
Janet Woodcock, FDA's Chief Medical Officer, on PAT, QbD and the Critical Path
02/04/2007
Duquesne University's Jim Drennan on PAT Calibration and Innovation
02/04/2007
Emil Ciurczak spoke with Professor Jim Drennan of Duquesne University on ISPE's Journal of Innovation and a new NIR spectroscopy calibration method.
TOC Talk with GE's Richard Godec
02/04/2007
Recently, there have been a number of changes at GE. Here, Emil Ciurczak chats with GE Analytical Instruments' Richard Godec about TOC analysis and its importance, as well as "the new GE."
Horiba's Lee Discusses Raman with Emil Ciurczak
02/04/2007
In this brief conversation at IFPAC 2007, Emil Ciurczak discusses Raman spectroscopy with one of Horiba's resident experts, Dr. Eunah Lee.
FDA's Moheb Nasr Discusses the Fine Points of Quality by Design at IFPAC
02/04/2007
FDA's Chris Watts on Standards and PAT within FDA
02/04/2007
CPAC's Mel Koch on PAT and the future of miniaturization
02/04/2007
FDA's Moheb Nasr Discusses QbD with Emil Ciurczak
02/04/2007
Ajaz Hussain introduces plenary speakers with reminiscences, shares new perspectives
02/04/2007
Podcasts from IFPAC: "Radio Free Emil"
01/29/2007
In these audio files, hot off the wire from the 2007 IFPAC Conference, Process Analytical Technologies expert Emil Ciurczak interviews leading PAT authorities from USP, FDA and the pharmaceutical industry.
Macher and Nickerson on Benchmarking Pharma and FDA
11/20/2006
Georgetown Professor Jeffrey Macher and Washington University Professor Jackson Nickerson discuss their extensive benchmarking project, which analyzed FDA regulation, in particular cGMP inspections, as well as industry manufacturing performance.
Pfizer's Warman and Pillai Lead AutomationXchange PAT Panel
08/31/2006
Pfizer's Jeff Miller, Martin Warman and Lou Pillai participated in a PAT Roundtable at AutomationXchange and hosted by Control magazine. Their mission, in large part, was to illuminate the differences between PAT and process analyzers.
Merck, Abbott, Genentech Address Success with Control, MES
06/22/2006
In the heat of Phoenix in June, hot topics at Honeywell's Users Group meeting included pushing process control to new levels and maximizing use of manufacturing execution systems.
Ciurczak Analyzes IFPAC '06
03/03/2006
NIR expert and Pharmaceutical Manufacturing columnist Emil Ciurczak discusses this year's conference in this downloadable audio file. For his article discussing highlights and key developments, see "IFPAC 2006 Under the Microscope."
Applying PAT to Vaccine Manufacturing
02/28/2006
In this audio interview at IFPAC, Mathieu Streefland of the Netherlands Vaccine Institute discusses the progress his group is making toward applying PAT to the unwieldy world of vaccine manufacturing.
VTT's Ralf Marbach on His New Calibration Method
02/04/2006
In this brief interview with Emil Ciurczak during IFPAC, Ralf Marbach discusses an alternative calibration method he developed at VTT in Finland.
Encapsulating Success
11/18/2005
High Point, N.C.-based Banner Pharmacaps is pushing the encapsulation envelope with veggie-based and anti-counterfeiting products, but manufacturing challenges abound, explains Aqeel Fatmi, Ph.D., global VP of R&D, in this exclusive Q&A.
Putting Nicotinic Compounds to Good Use along Tobacco Road
11/17/2005
R.J. Reynolds’ spinoff Targacept is the leader in using nicotinic compounds for therapeutic benefit. Bill Caldwell, VP of drug discovery and development, tells why and shares tech transfer secrets in this exclusive audio interview.
Operational Excellence: Straight Talk from BMS’ Wellemeyer
10/12/2005
How does a pharmaceutical manufacturing plant marked for closing transform itself into a corporate model (and home to Pharmaceutical Manufacturing’s 2005 Team of the Year)? Lean, 5-S and Factory Physics were all important, but people made the real difference. Listen in as John Wellemeyer, director of Bristol-Myers Squibb’s Indiana Technical Operations, shares best practices.
"What's In It for Me?" Taking PAT to the Executive Suite, Part 2
08/04/2005
In this audio interview at his offices in Dublin, Paraic O'Toole, CEO of Automsoft, talks about the issues affecting PAT's future. Instead of thinking "technology," he says, corporate executives should view PAT as a tool to improve share prices and profitability. PhRMA could play a far more active role in educating the top brass, and FDA support, at the Commissioner level, would speed PAT's adoption.
"What's In It for Me?" Taking PAT to the Executive Suite, Part 1
08/04/2005
In this audio interview at his offices in Dublin, Paraic O'Toole, CEO of Automsoft, talks about the issues affecting PAT's future. Instead of thinking "technology," he says, corporate executives should view PAT as a tool to improve share prices and profitability. PhRMA could play a far more active role in educating the top brass, and FDA support, at the Commissioner level, would speed PAT's adoption.
Grooming the Celtic Tiger for Drugmaking Dominance
07/22/2005
In this audio interview, Niall O'Donnellan, manager of life sciences and chemicals at Enterprise Ireland discusses developments in pharmaceutical manufacturing on the Emerald Isle. Enterprise Ireland is the government agency charged with stimulating entrepreneurship and the development of new companies in Ireland.