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  • Redefining the Workforce

    As competitive pressures increase, drug makers are becoming increasingly concerned about their “other” pipeline: the human one. Is today’s workforce up to the challenges now gripping the industry?

  • Don’t Dread PAT Pre-Op Reviews

    Look at FDA's PAT pre-op reviews as opportunities, suggests PAT expert David Radspinner. Focus on risk, and get FDA involved early.

  • First Things First: Understand Raw Material Quality

    Understanding the impact of raw material variability is critical to ensuring final product quality and to successfully initiating a PAT program.

    Paul Entrop, Product Team Director, Analyzers, Thermo Electron Corp.
  • Therapeutic Dose: Playing the Villain

    “The Constant Gardener” won’t help the wilting image of our industry, but it may open dialogue on global standards for clinical trials.

  • Handling Downsizings Right

    Downsizing offers a quick fix, but has long-term costs—and can even damage the bottom line. Whether you’re on the giving or receiving end, the right approach is critical.

  • Symbol’s Last Chance

    Two managements have struck out. The next may be the last chance for one of track & trace’s major players, says The WCCN Letter’s Tom Polizzi.

    Thomas A. Polizzi, WCCN Publishing
  • Overcome the Fear of Shear

    The mixing of biological products is delicate business, but concerns about shear sensitivity can be overblown. Rational process development, rules of thumb and tools like CFD can lead to fearless mixing.

    Thomas A. Post, Ph.D., Consultant, Post Mixing Optimization and Solutions
  • Sterilizing Filters: Right Flow, Right Size Critical

    Filtration can be the quickest, most cost-effective means to achieve sterilization for large volumes of simple buffers or aqueous solutions. However, finding the right flow rate and filter sizing is essential to meeting FDA’s aseptic guidelines.

  • Realizing ERP’s Untapped Potential

    Pharma ERP has been an underachiever for years; savvy drug makers are turning that picture around by connecting ERPs more closely to the plant floor.

    Doug Bartholomew, Contributing Editor
  • Advanced Process Control: Bridge the Gap

    PAT is the missing link in the evolution of pharmaceutical process control, but industry must act on the opportunity to realize expected gains.

    David Radspinner, Ph.D., Thermo Electron, and Matt Tormollen, Pavilion Technologies
  • A World Without Wires?

    The future is now for process monitoring via wireless instrumentation, while wireless process control looms.

  • Seven Commandments for Successful Integration

    Batch material transfer control seems an easy task to carry out. But the reality is that many functions are necessary if the system is to accomplish accurate batch material transfer control.

    Scott Little, Systems Engineer and Project Manager
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