Overview

This course introduces biopharmaceutical personnel to best practices, regulatory expectations and industry trends in the disciplines of facility cleaning, validation and environmental monitoring.

Instruction focused on essential industry guidance protocols that govern the effectiveness of cleaning procedures. Course materials cover facility cleaning methodologies, EM and validation procedures. Additionally, environmental monitoring theories and methods are implemented in order to validate cleaning processes and ensure that participants understand and are capable of implementing the actions needed to achieve industry standards.

This course is designed for biopharmaceutical manufacturers who need to develop and maintain high-quality, efficient, and compliant cleaning processes. Participants will be educated in the processes of cleaning and validation and will be prepared to work within their respective companies in accordance with standards and regulations that govern biopharmaceutical manufacturing.


Who should attend this course?

Individuals working in the Biomanufacturing industry including roles such as Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.


What are the course's objectives?

  • Gain practical knowledge and training in the areas of facilities cleaning, CIP, SIP and EM.

  • Learn how to effectively clean and sanitize biopharmaceutical manufacturing areas with understanding of environmental testing protocols and validation requirements.

  • Integrate the disciplines of Quality Assurance, Quality Control, Microbiology, Operations and Facilities Management.


Instructor(s)

Our courses are developed by content experts
with years of experience in delivering online eduction

Coordinator of Training

Beth Zielinski-Habershaw, Ph.D.

Dr. Zielinski-Habershaw has extensive biopharmaceutical experience in both academia and the private sector, covering all aspects of the biopharmaceutical and biomedical industry. She came to the PDI in 2019 after a two-year stint in business development at Advanced BioScience Laboratories in Rockville, MD. This is her second stint with the University of Rhode Island, having previously served as Co-Director of Biotechnology Manufacturing at the university. She has also served as a Director with the Center for Biological Engineering at Brown University, a Contract MSL with Medtronic Endovascular in California, and a Medical Writer with CRBard, Inc. in Warwick. Dr. Zielinski-Habershaw’s varied experience is a valuable benefit to the industry partners she works with as Coordinator of Training for the PDI.

How do you want to learn?

We have the solution that best meets your needs.

  • Fully Online

    Through this online learning platform.

  • Onsite

    Lecture & Lab at our facility in Kingston, RI.

Onsite

Learn hands on in a real GMP facility

This onsite course is delivered through a combination of a classroom presentation and hands on activities. The hands on activities take place in a clean gowned environment in our own GMP facility.

Preparation for the onsite learning is provided through the same self-paced content provided in our fully online course. Completion of this component of this course is necessary to participate in the onsite component. A full outline of the self-paced curriculum can be found at the bottom of this page.

A certificate of completion will be issued by the PDI when all components of the course are completed.


The onsite component of this course lasts for 5 hours, 3 of which are spent in the GMP lab facility.


Due to COVID-19 restrictions this course delivery option is currently not available.

Pre-order now to receive a notice with a $50 coupon when the course becomes available.


*Group discounts are available for all of our courses. Learn More



Fully Online

Learn at your own pace in your own place


This fully online course is delivered through this learning platform by a combination of video presentations, readings and quizzes. A full outline of the self-paced course can be found at the bottom of this page.

A certificate of completion will be issued by the PDI when all components of the course are completed.


There is approximately 5 hours of content in this course.  


$149*



*Group discounts are available for all of our course. Learn More



Self-Paced Content

Content Outline

  • 1

    Before you begin

    • How to use our platform
  • 2

    Course Overview

    • Introduction

    • Instructor: Beth Zielinski-Habershaw, Ph.D.

    • What will this this course provide?

    • After this course you will

    • Definitions

    • Course Hand Out
  • 3

    Module 1: Introduction to Pharmaceuticals and Biopharmaceuticals

    • Presentation

    • Review Quiz
  • 4

    Module 2: Who develops the guidelines for cleaning and environmental monitoring for the food and drug industries?

    • Presentation

    • Food and Drug Administration CFR 211

    • Review Quiz
  • 5

    Module 3: What type of facility will we be discussing?

    • Presentation

    • Review Quiz
  • 6

    Module 4: Why is cleaning and environmental monitoring required?

    • Presentation

    • Review Quiz
  • 7

    Module 5: How is cleaning performed and environmental monitoring used to validate the cleaning processes?

    • Presentation

    • Review Quiz
  • 8

    Module 6: When is cleaning and environmental monitoring required?

    • Presentation

    • Review Quiz
  • 9

    Challenges

    • Presentation

    • References