ComplianceOnline

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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