Renovating Existing Manufacturing Space to Accommodate Aseptic Fill/Finish

Instructor: Erich Bozenhardt
Product ID: 704665
  • Duration: 60 Min
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This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.

Why Should You Attend:

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. We have seen the engineering of facilities, compliance aspects and the retraining of staff is far more expensive than originally scoped, and has taken much longer than most organizations can tolerate.

This webinar will take participants through the ABCs of facilities conversion and assist in devising and implementing a bullet-proof plan, keeping in mind budget constraints.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Production managers
  • Plant managers
  • Engineers (quality, validation, facilities)
  • Quality operations managers
  • Those who need to communicate internally with engineering or operations personnel responsible for new production

Instructor Profile:

Erich Bozenhardt is the head of the process group of Integrated Project Services (IPS) in Raleigh NC. Mr. Bozenhardt has 10 years of experience in the biotechnology and aseptic processing business. He has led several biological manufacturing projects including cell therapies, mammalian cell culture, and novel delivery systems. Mr. Bozenhardt has a BS in Chemical Engineering and an MBA, both from the University of Delaware.

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