Improving Biological Facility Design: Critical Tips for Compliance
Building new biological facilities and renovating existing ones is a time-consuming and costly process. Many pharmaceutical companies delay any decision - making it almost too late to act. Combined with often ill-defined budgets, this type of dilemma ultimately manifests itself in massive compliance risks.
Improving facility design presents a unique opportunity to use new technologies and flexible design features to build a better facility that will maximize compliance and enable the launch of new products and therapies.
This seminar will explore the key design concepts that are currently driving the compliance and operability of business, and an “inside-out” view of a plant’s design model including: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. The course will explore modern technologies of facility deployment that can rein in costs and reduce schedules to provide you with specific guidelines that drive compliance to a successful conclusion.
Join us for this 90-minute, live, online seminar, where you will learn:
- The “ABCs” of facilities enhancement – compliance-driven actions that get results
- Devising and implementing a bullet-proof plan: reach goals, set expectations, and lower costs
- Develop flexible facilities that will allow your operations to scale without pain
This course will be of benefit to anyone involved in production, engineering, or quality operations of a biological facility; or a team member assigned to a new biological 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 38 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 Inc.
Mr. Bozenhardt has extensive experience in the 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 BS in Chemical Engineering and MS in System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).