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Aging Aseptic and Biological Manufacturing Facilities: Design and Renovation for Compliance
The pharmaceutical business has a global shortage of aseptic fill sites and flexible biological manufacturing plants. This is primarily due to the decade-long merger/acquisition and consolidation trends in the business.
This has forced facilities to produce and perform well beyond their anticipated useful lifespan.
The existing facilities have been forced to expand production, change product portfolios and most likely have undergone a change of ownership.
Most of these facilities have remained in a poor state and have weak infrastructure — even as the FDA and international regulators have pushed through substantial new GMP regulations, general engineering practices and innovative design philosophies.
This has resulted in massive compliance risks for drug sponsors and contract manufacturers.
This presentation will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years. Additionally, these proven strategies can enhance compliance, reduce the operating risks and provide more robust plant performance.
You will learn:
This course will be of benefit to anyone involved in aseptic or biological facilities, especially:
Herman Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise covers a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Mr. Bozenhardt is 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, Janssen Pharmaceuticals, Patheon, as well as operations positions within Pfizer. Mr. Bozenhardt has extensive experience in manufacturing therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg-based technologies. Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner and KBR. Mr. Bozenhardt has a B.S. in Chemical Engineering and an M.S. in System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).
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