The pharmaceutical business has a global shortage of aseptic fill sites and flexible biological manufacturing plants. This is primarily due to the decade-long mergers/acquisitions and consolidations in industry, driven by the financial pressures. This has forced facilities to produce and perform well beyond their anticipated useful lifespan. Existing facilities have been forced to expand production, change product portfolios, and – more than likely – undergo a change of ownership. The change of ownership has often not allowed the infusion of capital upgrades that are needed for technological advancement. Most of these facilities have remained in their basic state, and have a weak infrastructure, even as regulations, GEPs, design philosophies, and construction techniques have advanced. This situation has positioned these facilities below the standards of what the “c” in “cGMP” always intended.
This type of dilemma ultimately manifests itself in massive compliance risks, lost profits, and loss of market share. However, there are simple steps that can help you “stay ahead of the curve.”
This 90-minute interactive seminar will discuss the issues, design, and implementation of the following:
This course looks at key design features and philosophies that will drive compliance to a successful conclusion. Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.
Finally, this seminar will explore the design concepts that are driving compliance and the operability of businesses globally. This course will explore these critical aspects from a design and compliance perspective, plus provide you with specific guidelines and direction.
Join us for this 90-minute, live, online seminar, where you will learn:
This course will be of benefit to anyone involved in production, engineering, or quality operations of an aseptic or biological facility; or a team member assigned to a new biological/aseptic project. Additionally, those who need to be able to communicate internally with engineering or operations personnel responsible for new production will find this course extremely beneficial.
Herman Bozenhardt has 40 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance. He is a recognized expert in the area of aseptic filling facilities and systems and has extensive experience in the manufacture of therapeutic biologicals and vaccines. His current consulting work focuses on the areas of biotech technology transfer, biological manufacturing, and automation/computer systems. He has a B.S. in chemical engineering and an M.S. in system engineering, both from the Polytechnic Institute of Brooklyn.
Erich Bozenhardt is the Process Manager for IPS-Integrated Project Services’ process group in Raleigh, NC. He has 11 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems. He has a B.S. in chemical engineering and an MBA, both from the University of Delaware.