Archive for January, 2009

2009 Facility of the Year Award Winners Announced

Wednesday, January 28th, 2009

Six pharmaceutical manufacturing facilities constructed by companies located in Belgium, India, Ireland, Germany, and Switzerland have been selected as Category Winners in the fifth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. The companies and respective award categories include:

  • Aseptic Technologies, located in Gembloux, Belgium, winner of the Facility of the Year Award for Equipment Innovation
  • Centocor Biologics Ireland, located in Ringaskiddy, Cork, Ireland, winner of the Facility of the Year Award for Sustainability
  • Centocor R&D Schaffhausen, located in Schaffhausen, Switzerland, winner of the Facility of the Year Award for Facility Integration
  • Hameln Pharma, located in Hameln, Germany, winner of the Facility of the Year Award for Operational Excellence
  • Orchid Chemicals & Pharmaceuticals, located in Aurangabad, India, winner of the Facility of the Year Award for Regional Excellence
  • Roche Pharma Biotech Production Basel, located in Basel, Switzerland, winner of the Facility of the Year Award for Project Execution

In addition, GlaxoSmithKline Manufacturing was awarded an Honorable Mention for the company’s project in Verona, Italy.

For more information or to submit your facility, go to the Facility of the Year Awards web site.

Online Now: 2009 Tampa Conference Agendas and Course Outlines

Monday, January 26th, 2009

Go to the ISPE 2009 Tampa Conference page to view the seminar agendas and training course outlines for the 2009 Tampa Conference being held at the Grand Hyatt Tampa Bay in Tampa, Florida, USA on 2-5 March 2009,

Two-day seminars at Tampa Conference include:

  • Aseptic Processing: Fifth Annual Aseptic Manufacturing Technology Symposium
  • Downstream Processing: Developments and Case Studies
  • Assessing the Impact of Disposables: Achieving Operational Excellence, Minimizing Waste
  • Containment Technology Forum: Concepts, Case Studies, and Compliance
  • Implementation of GAMP® 5 Principles
  • Pharmaceutical HVAC Systems: Practical Approaches of Compliance and Sustainability
  • Two-day training courses at Tampa Conference will include:

  • Containment Fundamentals
  • Process Validation in Biotechnology Manufacturing
  • Facility Project Management in the Regulated Pharmaceutical Industry

  • INTERPHEX365.com Gives Pharma Professionals Online Advantage

    Friday, January 16th, 2009

    INTERPHEX.365.com, the new online joint venture by INTERPHEX and ISPE, is a pretty cool way for Life Sciences professionals to obtain news, product information, career opportunities, and networking opportunities from the comfort of their own computers. The web site is an on-the-fly, one-stop shop for all of the aforementioned resources, as well as offering a comprehensive global supplier directory. The directory is designed to provide a broad view of the current supplier base with which professionals can search.

    FDA’s Torti Tapped As Acting Commissioner; Interim Heads Also Named For HHS, CMS

    Tuesday, January 13th, 2009

    BREAKING NEWS FROM “THE PINK SHEET” DAILY———————————–

    FDA’s Torti Tapped As Acting Commissioner; Interim Heads Also Named For HHS, CMS
    After months of intense speculation, FDA chief scientist and principal deputy commissioner Frank Torti will become acting commissioner of the agency upon Andrew von Eschenbach’s departure Jan. 20.

    That decision - along with the transition plans for other top HHS agencies come Inauguration Day - was announced in an email message sent to department staff by HHS Chief of Staff Rich McKeown on Jan. 9.

    HHS Secretary Michael Leavitt will leave the department once President-elect Obama takes office. Assistant secretary Charlie Johnson will become acting HHS secretary “between January 20 at noon and the time when Secretary-designate Daschle is sworn in,” McKeown’s email says.

    The Centers for Medicare & Medicaid Services will be headed by chief operating officer Charlene Frizzera; acting CMS administrator Kerry Weems will step down;

    The entire breaking news story is posted at “The Pink Sheet” DAILY online.

    Validation Process Webinar Allows US FDA Interaction

    Wednesday, January 7th, 2009

    As part of its continued Online Learning initiative, ISPE has announced plans to host a live webinar on 13 January that will allow participants to interact with representatives of the US FDA and discuss critical process validation guidelines. For more information on this opportunity, check out the information and registration page for this webinar on ISPE’s web site.