ISPE to Present Conferences Focused on Pharmaceutical Aseptic Processing

The two-day events will address the challenges companies face in producing sterile pharmaceutical products. The first conference will take place in Tampa, Florida USA on 29 February - 1 March 2012. A similar program, with a strong focus on European concerns, will be offered in Frankfurt, Germany on 26 - 27 March 2012.

Attendees will learn from leading manufacturing experts on barrier isolation, vaccine manufacturing, and technology innovations related to aseptic processing. Each track will draw heavily from the recently released, FDA-reviewed ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition), the industry's go-to Guide for aseptic processing. Attendees will receive a complimentary copy of the Guide, a US$465 value.

“As the technical voice of manufacturing and engineering in the pharmaceutical industry, ISPE is committed to presenting programs that facilitate relevant dialogue and the sharing of best practices among industry leaders, manufacturing experts and leading regulators,” said ISPE's new President and CEO Nancy Berg. “At a time when manufacturing operations are under tremendous pressures to improve effectiveness, deliver quality and reduce costs, ISPE is responding with new programs and conference formats that feature dynamic and focused session content. Our events are developed to deliver information, discussion and networking that lead to new ideas, problem-solving and process improvement concepts that, when applied, have positive bottom-line results.”

Titled “Global Evolution of Aseptic Processing: Implementing Risk-Based Manufacturing Solutions,” the conferences will feature three keynote presentations from recognized industry experts in aseptic processing:


• William Weidersiem, President & CEO, PharmaBioSource, Inc., USA
The Market for Parenteral Products and Facilities

• Udo J. Vetter, Vetter Pharma Fertigung GmbH & Co. KG, Germany
Why Vaccines Are No Longer in Vials

• Mark Von Stwolinski, Vice President Architectural Services, CRB Consulting Engineers, Inc., USA
Special Presentation on the ISPE Sterile Guide by Co-Author

The conferences will contain three distinct tracks:

• A Barrier Isolation track led by Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA.
• An Aseptic Technologies for Vaccine Manufacturing track led by Jeffrey Biskup, President and CEO, CRB Consulting Engineers, Inc., USA.
• A Technology Innovations in Aseptic Processing track led by Joerg Zimmermann, Director Process Development and Implementation, Vetter Pharma Fertigung GmbH & Co. KG, Germany.

For more information on these conferences, including detailed agendas and registration information, visit here (Tampa) or here (Frankfurt).

Additionally, related training courses will be offered in conjunction with both events:

• In Tampa, a new course titled “Sterile Product Manufacturing Facilities: Applying the new ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation,” will be offered immediately preceding the conference on 27 - 28 February 2012. Detailed information on this course can be found at here.
• In Frankfurt, two training courses will be offered immediately following the conference, on 28 - 29 March 2012. “Facility Project Management in the Regulated Pharmaceutical Industry” and “Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide.” Detailed information on these courses can be found at here.