Join ISPE DVC for an education event exploring aging aseptic facilities and learn how to fix them. Evolving regulatory requirements in addition to today’s COVID environment has created incredible pressure on existing aseptic filling capacity around the globe. This pressure is increasing the number of older facilities that need to be upgraded to bring therapies to patients.
In this one-hour lunch and learn, participants will learn the following:
· What is an aging facility? What are its characteristics and flaws?
· How facilities age and deteriorate
· How to renovate existing facilities with a focus on reducing bioburden
This one-hour event will be held virtually and will be presented by Herman Bozenhardt, a former industry executive and widely recognized expert in all aspects of aseptic filling facilities design, construction and commissioning. There will be time for a Q&A with Herman and all participants will earn one Professional Development hour for attending. Participants will be able to sign on around 11:45.
Thank you in advance for registering and we look forward to seeing you (virtually) on Tuesday, October 27.
Speaker/Presenter Info/Bio:
Herman Bozenhardt
Herman Bozenhardt is a former industry executive with 44 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt has a wide spectrum of expertise which includes process design, facility engineering, regulatory compliance and computer systems technologies. He is a recognized expert in the area of aseptic filling facilities with extensive experience in the design, engineering and construction of manufacturing facilities for therapeutic biologicals and vaccines.
Mr. Bozenhardt is a frequent contributor to ISPE, a monthly guest contributor to Bioprocessing Online and Pharmaceutical Online and the developer of an extensive webinar series on aseptic facility design. He is also the co-contributor to the podcast series “Biotech with the Bozenhardt’s” and the developer of three e-books that can be accessed HERE . He is the author of more than 100 technical papers.
Mr. Bozenhardt has a BS Chemical Engineering and a MS System Engineering from the Polytechnic Institute of Brooklyn.