2009

61-80 of 265 < first | | | last >
  • Webinar: Staying One Step Ahead of the FDA: Supplier Audits and Ensuring Raw Material Quality

    To avoid costly shutdowns, product seizures, and warning letters, drug firms need effective raw material controls and critical supplier auditing procedures. Imagine how effective your controls would be if you were using the same exact field sampling techniques and tools FDA investigators use. If you’d like to learn some of the lessons the FDA has adopted in the wake of the contaminated Heparin and Glycerin scandals, then attend this free webinar hosted by Thermo Fisher Scientific.

    08/31/2010
  • Focus on Pharma Episode 8: Pharmaceutical QbD: An Industry Progress Report Led By Ali Afnan

    Faster drug approvals, real-time release, regulatory relief. These, and many other benefits, are promised by adopting Pharmaceutical Quality by Design principles. So why aren't more people embracing the concept? Skeptics continue to see QbD efforts as too expensive, time consuming and impractical, while QbD and PAT projects are being launched separately, rather than together as intended. Exploring the reasons for this apparent disconnect, and potential solutions, are Ali Afnan, Pedro Hernandez-Abad, Sam Venugopal and Gawayne Mahboubian-Jones.

    08/26/2010
  • Webcast: Best Practices Rapid Deployment for Pharmaceutical Manufacturing

    SAP is helping Life Science companies implement comprehensive and proven industry specific solutions that manage business processes in one preconfigured Life Science industry solution. Join us to learn how Convatec implemented an SAP Life Science industry solution using industry best practices and rapid deployment methodologies to meet an aggressive implementation timetable and develop a solid foundation to support future growth in the highly regulated Life Science industry.

    SAP
    08/20/2010
  • Podcast: API Pollution: Are Drug Manufacturers Trying to Stymie Studies?

    A recent U.S. Geological Survey study found two drug facilities in New York state releasing high levels of API into local groundwater. The manufacturers have been less than cooperative, says study lead Patrick Phillips, speaking with Senior Editor Paul Thomas. Without adequate studies, Phillips adds, there's no way of knowing what the impact of the compounds on local biota might be.

    08/09/2010
  • From SharePoint to Cloud Computing: Microsoft's Life Sciences Evolution

    Microsoft is positioning SharePoint as a solution to the industry's innovation gap. In this interview with Senior Editor Paul Thomas at DIA 2010, Michael Naimoli, Director of Life Sciences Industry Solutions, discusses how manufacturers like GSK and Merck are using SharePoint as a knowledge management platform to find new ways to innovate.

    08/09/2010
  • Webcast: As Your Markets Grow, Can Your Data Management Systems Keep Up?

    SAP is helping Life Science companies implement comprehensive and proven industry specific solutions that manage business processes in one preconfigured Life Science industry solution. Join us to learn how Convatec implemented an SAP Life Science industry solution using industry best practices and rapid deployment methodologies to meet an aggressive implementation timetable and develop a solid foundation to support future growth in the highly regulated Life Science Industry.

    08/04/2010
  • What Is the "One Pfizer Culture"?

    Pfizer's Chief Diversity Officer Ed Gadsden tells how global colleague-resource groups help the pharmaceutical giant work together to better serve underrepresented patient communities.

    08/04/2010
  • Focus on Pharma Episode 6: Continuous Processing: Is Pharma Moving Beyond the Batch?

    Although batch manufacturing promises to dominate drug manufacturing, there are a growing number of opportunities to harness the power of continuous manufacturing. Is the industry reaching a tipping point? Bernhardt Trout, head of the Novartis-MIT Center for Continuous Manufacturing, shares his views on what is changing.

    06/23/2010
  • Webcast: QbD: A Look Ahead

    Design for manufacturing is helping to drive continuous improvement in most industries today. Quality by Design, driven by ICH, FDA and other regulatory agencies, aims to take that approach to drug development, to reduce the time and cost of bringing new drugs to market. The past few years have seen pilot QbD programs, case studies for small molecules and biopharmaceuticals and the sharing of information. How far has the concept come in the pharma industry? What will be needed to drive it forward in the future?

    06/22/2010
  • Flowing Over: Continuous Manufacturing Finding a Home in Pharma

    The significant uptake of continuous processing in pharma coincides with technologies that enable it. Most of the technology gaps have been filled, says Microfluidics' CTO Mimi Panagiotou, PhD, who discusses why continuous processing is reaching a tipping point in pharma now, and various ways that manufacturers are using her company's MRT reactors for continuous crystallization and multi-phase reactions.

    06/21/2010
  • Automating R&D Workflows, Searching for Step-Change Productivity Gains

    Freeslate is working with J&J and other pharma clients to automate and integrate diverse workflows within pharma labs and make analytical data more accessible to development scientists. We talk with CEO John Senaldi to get a better sense of his company's solutions, including the benefits of Lab Execution & Analysis (LEA) software.

    06/21/2010
  • Contract Manufacturing: Ensuring Continuity in Tech Transfer

    Metrics, Inc. has grown from an analytical outfit into a full-blown CDMO. Clients expect not just speed in development, but continuity through to commercial manufacture. VP Dave Varley, speaking at Interphex 2010, explains how to ensure seamless tech transfer by keeping key people in close and constant communication.

    06/15/2010
  • Webcast: Applying Lean in the Lab

    Toyota methods may have been designed for the shop floor, but they are leading to significant improvements in the way pharmaceutical quality and even research labs operate. Hear leading consultants--Tadgh Prendeville, BSM USA and Bikash Chatterjee, Pharmatech Associates as well as Margaret Wyche, Director of QC, Allergan share their experiences on increasing efficiency, decreasing waste and improving quality in the lab.

    06/14/2010
  • Episode 5: John Avellanet and Gawayne Mahboubian-Jones on Redefining Pharmaceutical Quality

    Gawayne Mahboubian-Jones, program manager for excellence in science and design with Philip Morris International, and consultant and former pharma CEO John Avellanet author of "Get to Market Now!" discuss what is needed to drive, and sustain, continuous quality improvement in the drug industry. Customer focus and C-level connection to quality and compliance will be key.

    06/07/2010
  • Single-Use Systems and Automation: An Unhappy Marriage?

    There's an obvious need for improved process control and monitoring with single-use bioprocess equipment and systems. It's a matter of maturity, and integration, says Sartorius Stedim's Paul Priebe. He puts the burden on the supplier community: "We can't just provide our customers with a box of legos," he says. Single-use technologies have to be more integrated and standardized.

    06/02/2010
  • Riera: "Puerto Rico is Open for Business"

    Puerto Rico's Secretary of Economic Development Jose Perez Riera discusses the country's efforts towards increased R&D and the recent biotech incentives being offered to steer growth.

    05/21/2010
  • CMO Searching: Just Point and Click?

    For drug companies looking for manufacturing support, finding a CMO with the appropriate capabilities is a challenge. CMOLocator.com is a search engine whose aim is to simplify the search process, while providing a broad and deep database. Kevin Brown explains, at BIO 2010.

    05/21/2010
  • BIO 2010: Kidding Around with Shionogi's Sico

    Shionogi's Robot, Sico, takes time at BIO to speak with us about how automated robots are helping autistic and special-needs children in hospitals and organizations around the country.

    05/20/2010
  • Successes & Challenges for Females in the Life Sciences

    Sr. Digital Editor Michele Vaccarello Wagner speaks with Women in Bio President Lynn Johnson Langer and Board Member Robbie Melton about the recent surge of women entrepreneurs in the life sciences and the challenges young women face in biotech.

    05/20/2010
61-80 of 265 < first | | | last >