2007

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  • Top Eight Health Industry Issues in 2008

    To help health executives and policy makers anticipate and prepare for what's ahead, PricewaterhouseCoopers’ Health Research Institute has identified the Top Eight Health Industry Issues in 2008. The report highlights impending changes — ranging from major changes in provider reimbursement, to new drug safety reporting requirements, to a potentially burgeoning market for individual health insurance — and how they could impact health organizations.

    PriceWaterhouse Coopers
    12/19/2007
  • A Perspective on Standards

    This white paper by Rockwell Automation features executive viewpoints from leading standards, trade and conformity assessment organizations on why standards and regulations are important to global business, and why industry should care.

    Rockwell Automation
    12/17/2007
  • Amendment to the cGMP Regulations for Finished Pharmaceuticals

    The FDA is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Amending the regulations will modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.

    FDA
    12/07/2007
  • Manufacturing IQ: Taking Manufacturing Intelligence to the Enterprise

    Aberdeen research shows that top pressure driving manufacturers towards Enterprise Manufacturing Intelligence (EMI) initiatives is to increase productivity without additional capital investments. This benchmark report shows Best-in-Class companies more than two times as likely as other companies to have implemented EMI to address this key market pressure and achieve efficiencies within their factories and across the supply chain. Best-in-class enterprises that implement EMI utilize it across the supply chain network with real-time linkages to customers for order pegging and real-time visibility.

    Bharat Nair and Mehul Shah, Aberdeen Group
    11/06/2007
  • The Impact of Nanotechnology in Drug Delivery: Global Developments, Market Analysis, and Future Prospects

    This report by NanoMarkets, LC includes an overview of nanoenabled drug delivery technologies, commercial applications and information on the companies pursuing them, information on nanotechnology initiatives and regulation in major international markets (North America, EU, Japan, Israel, etc.), as well as eight-year worldwide forecasts on the industry’s anticipated growth and timing thereof.

    NanoMarkets, LC
    11/01/2007
  • Virus Testing For Biological Products: Partnering With a Contract Lab

    This paper by Microtest Laboratories is an introduction to the virus testing that is required for biological products. When working with a contract testing supplier, each product must be evaluated individually and given the customized treatment it needs. The contract testing supplier should be a partner in the process to ensure that the virus safety requirements are met, and the testing strategy is tailored for each company and product.

    Microtest Laboratories
    11/01/2007
  • Pharma Futurology: 2016 and Beyond

    This report by British Telecommunications provides a bird’s eye view of the pharmaceutical industry, and where it might be in a decade’s time: how pharmaceutical firms will be connected to the wider healthcare ecosystem, and what technologies will glue it together.

    British Telecommunications
    10/16/2007
  • Pharmaceutical and Biotechnology Update : Drug Pedigrees

    This update summarizes the pending Prescription Drug Marketing Act requirements, highlights pedigree requirements in Florida and California, and raises issues for consideration.

    Meredith Manning, Michael L. Kidney, and Ellen Y. Chung, Hogan & Hartson
    08/28/2007
  • Official File : Novartis Complaint

    This is the official filed action against Novartis Pharmaceutical Corporation for violating a whistleblower's rights under the New Jersey Conscientious Employee Protection Act and retaliating against him for refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Novartis' new cancer drug, Tasigna.

    07/27/2007
  • Particle Counting in Injectable Solutions

    This paper, by Particle Measuring Systems, in its third revision, discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that injectable solutions are effectively monitored for microcontamination, specifically non-soluble particulates.

    Particle Measuring Systems
    07/17/2007
  • Achieving Optimal Particle Size Distribution in Inhalation Therapy

    Obtaining consistent, appropriate particle size for certain inhaled drugs has been a troublesome task. Pharmaceutical companies are currently developing methods for producing aerosolized formulations containing uniform, optimally sized particles.

    Bob Bruno, Microfluidics Corp.
    07/17/2007
  • A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials

    This comprehensive guide written by The Institute of Quality Assurance is aimed at increasing the awareness of the quality management system requirements embodied in PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies to illustrate areas of GMP risk.

    The Institute of Quality Assurance
    07/16/2007
  • Environmental Testing : Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers

    Industrial sterilization and contamination control programs are critical in pharmaceutical and medical device manufacturing. This article by Microtest Labs reviews the key elements of a best practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. In this paper, the author draws on his extensive experience assisting clients with program development. He reviews strategies that range from the essentials of compliance to budget development and management.

    Microtest Laboratories
    07/10/2007
  • Podcast: FDA's Dr. Janet Woodcock on New Directions for FDA in 2007

    In February, 2007, after she was named Chief Medical Officer of FDA, Dr. Janet Woodcock spoke about how she plans to bring new science and an atmosphere of open debate to the Agency, and how the concepts of manufacturing science can reshape R&D and clinical work, and, ultimately, make medicine less of an art and more of a science. She also spoke about changes she's seen in the industry since CDER published the 21st Century GMPs, PAT and Quality Systems guidance documents.

    07/09/2007
  • Customer First...and Last

    All the skills that are key to Six Sigma Leadership are put to their ultimate test in this challenge of balancing customer needs and your organization’s self-interest today while being always ready to change with the customer, or to begin serving new customers.This chapter from Peter Pande's "The Six Sigma Leader" will review ideas and approaches to building a more solid and practical approach to increasing customer focus balanced by the need for flexibility and long-term success. These approaches will increase your odds of staying connected to a group of satisfied — and profitable — customers.

    Peter Pande
    06/29/2007
  • Podcast: Six Sigma for Pharmaceutical Innovation: An Interview with Peter Pande

    In this podcast interview, the Six Sigma consultant and best selling author discusses typical mistakes that pharmaceutical companies make when approaching Six Sigma, and why a broader approach is necessary. He also tells how Six Sigma can be applied to pharmaceutical R&D. Remember, he says, that facts can be more important than numbers in many situations outside of manufacturing, and that a different approach will be needed for each part of the business.

    Peter Pande
    06/21/2007
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