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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
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      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
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      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
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    • Training Voucher Packages
    • Checkout
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    • LSTI Corporate Learning Library
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HomeManufacturing & Good Manufacturing Practices (GMP) TrainingAging Biotech and Aseptic Facilities – Renovation for Survival

Aging Biotech and Aseptic Facilities – Renovation for Survival

Teachers
Erich Bozenhardt
Herman Bozenhardt
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Research & Development/
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The pharmaceutical business has a global shortage of aseptic fill sites and flexible biological manufacturing plants. This is primarily due to the decade-long mergers/acquisitions and consolidations in industry, driven by the financial pressures. This has forced facilities to produce and perform well beyond their anticipated useful lifespan.  Existing facilities have been forced to expand production, change product portfolios, and – more than likely – undergo a change of ownership. The change of ownership has often not allowed the infusion of capital upgrades that are needed for technological advancement. Most of these facilities have remained in their basic state, and have a weak infrastructure, even as regulations, GEPs, design philosophies, and construction techniques have advanced. This situation has positioned these facilities below the standards of what the “c” in “cGMP” always intended.

This type of dilemma ultimately manifests itself in massive compliance risks, lost profits, and loss of market share.  However, there are simple steps that can help you “stay ahead of the curve.”

This 90-minute interactive seminar will discuss the issues, design, and implementation of the following:

  • Unidirectional flows and architectural layout
  • HVAC upgrades, AHU modernization, segregation, isolation, and distribution
  • Architectural finishes and upgrades
  • Use of single use / disposables process systems
  • Automation of portable systems
  • Operational upgrades in the area of material handling

This course looks at key design features and philosophies that will drive compliance to a successful conclusion.  Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.

Finally, this seminar will explore the design concepts that are driving compliance and the operability of businesses globally. This course will explore these critical aspects from a design and compliance perspective, plus provide you with specific guidelines and direction.

LEARNING OBJECTIVES

At the conclusion of this 90-minute session, participants will be able to:

  1. The “ABCs” of facilities enhancement – compliance-driven actions that get results
  2. Focus on the removal of the sources of contamination and particulate generation
  3. Design, engineering and construction “must do” items
  4. Devising and implementing a bullet-proof plan: reach goals, set expectations, and lower costs
  5. Develop flexible facilities that will allow your operations to scale without pain

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in production, engineering, or quality operations of an aseptic or biological facility; or a team member assigned to a new biological/aseptic 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.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Erich Bozenhardt
Erich Bozenhardt has 11 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems.
Herman Bozenhardt
Herman Bozenhardt has 41 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance.

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Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
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TOPICS

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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