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FDAnews Announces — The Biopharmaceutical Facility of the Future: To 2025 and Beyond Webinar, Sept. 29, 2015
Date:9/11/2015

The Biopharmaceutical Facility of the Future:
To 2025 and Beyond
**FDAnews Webinar**
Sept. 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/biopharmaceuticalfacility

The biopharmaceutical facilities that are designed, built and renovated today — while evolving to accommodate new process technology and multiple products — will bear little resemblance to facilities of the future. Drivers of transformation in the industry include:

  •     Global regulatory harmonization
  •     Return on investment
  •     Relocation/adaptation to areas with more favorable tax structures
  •     Speed of product introduction
  •     Scalability at a rapid pace, as needed
  •     The ability to repurpose a facility, process or equipment instantly
  •     Mergers, acquisitions, and divestiture

Manufacturers will continue to focus on large molecules, novel delivery systems, and continuous processing; they’ll use small batch sizes to accommodate both the requirements of lower risk for high-value and high-volume products, and more individualized medicines. Thus, the facilities, processes, and filling will be profoundly different, even as the packaging remains recognizable. The financial drivers mentioned above will force a revolution in the process area, and developments such as:

  •     Fully contained and disposable process equipment
  •     Inert system with no exposure to any atmosphere
  •     Pod-based, autonomous facilities/rooms
  •     Robotic assembly/disassembly of processes
  •     Humans existing only in ISO 8 environments
  •     PAT- and sensor-based quality control and release

In this webinar, Herman and Erich Bozenhardt will explore the commercial factors which are driving the industry and often not towards success. Second, they’ll discuss the establishment of a joint global regulatory agency. Based on the business aspects, they’ll define future process requirements and provide a view of how change is accelerating from evolution to revolution. Finally, with the processes designed, they’ll discuss what manufacturing plants will eventually become and how they’ll support compliant production.

Attendees will get an inside-out view of a future plant’s design model: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. This webinar will explore these critical aspects, expose attendees to technologies available today from a design and compliance perspective, and provide specific guidelines and direction on how to them right now.

Specifically attendees will learn:

  •     The process technologies driving the future of the business
  •     A glimpse of the minimalist, modular state that companies will evolve towards
  •     The future of compliance — a singular “bullet-proof” concept without contamination
  •     What to do today to enhance production and become part of the revolution

Meet the Presenters:

Herman Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, and Janssen Pharmaceuticals, as well as operations positions within Pfizer.

Erich Bozenhardt is the head of the process group of the IPS Engineers in Raleigh NC. Mr. Bozenhardt has 10 years of experience in the biotechnology and aseptic processing business. Mr. Bozenhardt has led several biological manufacturing projects including cell therapies, mammalian cell culture, and novel delivery systems.

Who Will Benefit:

  •     Compliance officers
  •     Engineering and design controls teams
  •     Executive management
  •     Managers
  •     Manufacturing directors and supervisors
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     Risk management specialists
  •     Strategic planning and business development staff
  •     Validation specialists, scientists, engineers

Conference Details:
The Biopharmaceutical Facility of the Future:
To 2025 and Beyond
**FDAnews Webinar**
Sept. 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/biopharmaceuticalfacility

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/biopharmaceuticalfacility
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/biopharmaceuticalfacility/prweb12956402.htm.


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