Improving Biological Facility Design: Critical Tips for Compliance

Teachers
Erich Bozenhardt
Herman Bozenhardt
Category:
Manufacturing/Regulatory & Compliance/Research & Development/On Demand Courses/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Building new biological facilities and renovating existing ones is a time-consuming and costly process.  Many pharmaceutical companies delay any decision – making it almost too late to act. Combined with often ill-defined budgets, this type of dilemma ultimately manifests itself in massive compliance risks.

Improving facility design presents a unique opportunity to use new technologies and flexible design features to build a better facility that will maximize compliance and enable the launch of new products and therapies.

This seminar will explore the key design concepts that are currently driving the compliance and operability of business, and an “inside-out” view of a plant’s design model including: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. The course will explore modern technologies of facility deployment that can rein in costs and reduce schedules to provide you with specific guidelines that drive compliance to a successful conclusion.

LEARNING OBJECTIVES

Join us for this 90-minute seminar, where you will learn:

  1. The “ABCs” of facilities enhancement – compliance-driven actions that get results
  2. Devising and implementing a bullet-proof plan: reach goals, set expectations, and lower costs
  3. 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 a biological facility; or a team member assigned to a new biological 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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