Archive for the 'Media Coverage & Press Releases' Category

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

  • ISPE-PCC Awards New Industry Credential to Professional

    Tuesday, March 11th, 2008

    Elizabeth Martinez Flores, Director General for Terra Farma in Mexico City, Mexico, has met the global competency standard and has been conferred the Certified Pharmaceutical Industry Professional (CPIP SM ) credential by the ISPE Professional Certification Commission (ISPE-PCC).

    Martinez Flores is one of the seven professionals to be awarded this new certification and was assessed through demonstrated education, industry experience, and a rigorous examination. The new credential offers the first competency-based international certification for pharmaceutical professionals and covers a range of competencies from drug product development through manufacturing.

    The new certification offers enhanced credibility, peer respect and recognition, and greater opportunities for professional advancement.

    Martinez Flores has been an ISPE Member since 2002. She has a Bachelor’s degree as a Chemical Pharmaceutical Biologist from the Autonomous National University of Mexico, and a Master’s degree with Honorary Mention in Industrial Management from the Autonomous National University of Mexico.

    Martinez Flores has extensive experience as an auditor and speaker in Brazil, Chile, Colombia, the Dominican Republic, El Salvador, Mexico, Peru, Venezuela, and the United States, including Puerto Rico. She has expertise in quality systems, good manufacturing practices, handling and dispensation of drug products in pharmacies, among other topics. She has been a speaker in numerous national and international meetings — including ISPE — and at least 25 other organizations.

    In addition, Martinez Flores is certified by the American Society for Quality as an HACCP auditor, a quality auditor, quality manager, biomedical auditor, and a quality improvement associate. She is also an RABQSA-certified quality auditor, a COFEPRIS-recognized speaker, and has been certified by the Mexican Institute of Normalization and Certification.

    To learn more and obtain a CPIP eligibility application (free download) visit www.ispe-pcc.org.

    2008 Facility of the Year Awards (FOYA) Winners Announced

    Monday, February 4th, 2008

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

    • Boehringer Ingelheim Pharma GmbH & Co.KG, located inBiberach, Germany, winner of the Facility of the Year Award for Facility Integration
    • Bristol-Myers Squibb, located in New Brunswick, New Jersey, USA, winner of the Facility of the Year Award for Equipment Innovation  
    • IDT Biologika GmbH, located in Dessau-Rosslau, Germany, winner of the Facility of the Year Award for Operational Excellence
    • Pfizer, located in Illertissen, Germany, winner of the Facility of the Year Award for Process Innovation
    • F. Hoffmann La Roche AG, located in Basel, Switzerland, winner of the Facility of the Year Award for Project Execution

     The Awards Program is truly global, as submissions over the past four years have been received from at least 20 different countries and territories.   

    Visit www.facilityoftheyear.org for more information.

    Two-day Seminar on Disposables at ISPE Conference

    Wednesday, January 23rd, 2008


    Tampa, Florida, 25-26 February 


    You can attend Single-use Manufacturing Technology: Selection, Implementation, and Validation seminar at ISPE’s 2008 Manufacturing Excellence Conference. This seminar will provide the reasoning behind use of disposables in biopharmaceutical manufacturing and how to evaluate what is best for your company.
    Also gain insight on application of disposables in the design phase with equipment standardization concerns and environmental considerations.

    Potential end users, learn what to plan for when implementing single-use disposables, including compatibility, performance, single-use manufacturing, options, and new tools. Suppliers, learn end user concerns and join in discussion on the current state of applications. Attendance recommended for all professional levels of end users in the areas of biopharmaceutical manufacturing, formulation, aseptic filling, validation, and quality.

    Communities of Practice (COPs): Disposables, Biotechnology, and API

    Session leaders: Jerold Martin, Sr VP, Global Scientific Affairs, Pall Life Sciences, and Miriam Monge, Former Director of Marketing Stedim Biosystems and ISPE Disposables Community of Practice Chair

    Learn More/Register On-line Today