ComplianceOnline

Renovation of Aging Aseptic and Biological Facilities

Instructor: Erich Bozenhardt
Product ID: 704789
  • Duration: 60 Min
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In this training program, attendees will explore modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks, and improve performance.

Why Should You Attend:

This course will explore the modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities, including:

  • How unidirectional flows and architectural layout can boost productivity
  • Why upcoming intense FDA inspections should have you considering HVAC upgrades, AHU modernization, segregation, isolation and distribution
  • Best practices in architectural finishes and upgrades can reduce operating risks
  • Single use/disposables process systems have been deemed by many to be the future of manufacturing — how can you safely and compliantly build out these systems
  • How to use automation and portable systems to deliver product faster
  • The top operational upgrades in material handling that every manufacturing professional should know

Areas Covered in the Webinar:

  • The ABCs of facilities enhancement – compliance-driven actions that get results
  • Focus on the removal of the sources of contamination and particulate generation
  • Design, engineering and construction must do items
  • 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

Who Will Benefit:

  • Aseptic drug and biologic company executives
  • 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. He 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 Chemical Engineering degree and an MBA, both from the University of Delaware.

Topic Background:

Decades of mergers, acquisitions and business consolidations have resulted in a global shortage of aseptic fill sites and flexible biological manufacturing plants.

Many of the existing sites are in poor condition with generally weak infrastructures, producing and performing well beyond their anticipated useful life span. On top of maintaining the current state of the facility substantial new GMP regulations, general engineering practices and innovative design philosophies introduced by the FDA and international regulators have added pressures. Of course, if you are a drug sponsor or contract manufacturer, there are massive compliance risks awaiting you in these facilities.

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