Renovating Pharmaceutical Manufacturing Facilities for Aseptic Fill/Finish: Critical Planning, Execution & Compliance Tips
A growing amount of aseptic and non-aseptic fill facilities in North America are being challenged to add aseptic filling and finishing capacity of more aseptic products to meet the growing needs of industry. These demands require facilities to have unprecedented flexibility, be compliant to the Annex I guidelines, and comply with EU guidelines.
The immediate response to this challenge is generally "yes we can.” However, the engineering conversion of the space to accommodate these products involves far more than building a few walls and adding equipment. In reality, the engineering of facilities, compliance considerations, and the retraining of staff is far more expensive than originally scoped, and has taken much longer than most organizations can tolerate.
This course will give you the foundational tools necessary to identify changes that need to be made, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.
Join us for this 90-minute, live, online seminar, where you will learn:
- The “ABCs” of facilities conversion – critical points to ensure success
- Devising and implementing a bullet-proof plan: reach goals, set expectations and satisfy budget constraints
- How to ensure the “intangibles” aren’t overlooked – train your people, weave in compliance for a seamless transition
- 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 an aseptic filling facility or a team member assigned to a new aseptic project. Additionally, those for communicating internally with engineering or operations personnel responsible for new production will find this course extremely beneficial.
Mr. Herman Bozenhardt has 38 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise covers a wide spectrum of process, engineering, compliance, 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, 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 Chemical Engineering and MS System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).