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Addressing Biofilm and Other Non-Routine Microbial Events

Oct 28, 2019
Bethesda, MD

  • Education
  • The Americas


Please be advised that training course 537 Addressing Biofilm and Other Non-Routine Microbial Events has been rescheduled to Oct 28.

Regulatory agencies and senior management are placing more emphasis on how individuals and organizations respond to non-routine microbial events including single and multi-species biofilm contamination. The preference is to apply a scientific, risk-based approach to address non-routine microbial events.

This training course will provide an overview of contamination control best practices. It will demonstrate the setup and operation of the ASTM and EPA approved high shear CDC biofilm reactor and single tube test methods. The case studies on addressing non-routine microbial events are derived from visiting hundreds of sites around the world to investigate non-routine events. The review of the case studies will provide confidence in asking the right questions, assessing severity, understanding the critical parameters and quality attributes, investigating different options, and ultimately applying a corrective action or preventive maintenance approach to address the root cause. Understanding the root cause through constructive brainstorming and investigation will reduce unscheduled corrective action activities and reduced manufacturing delays and impact to product.


  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.


Paul T. Lopolito
Paul T. Lopolito
STERIS Corporation
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Evaluate contamination control best practices
    2. Compare and contrast the different risk-based tools
    3. Apply various risk-based approaches to real-world case studies to address non-routine events
    4. Evaluate and discuss laboratory test results using the methods on single species biofilms under various conditions
    5. Describe the different steps in a risk-based flow diagram
  • Who Should Attend

    This training course is intended for professionals who are directly involved in non-routine microbial events and risk assessment activities.

    Quality, Manufacturing, Technical Support, Engineering

    Supervisor, Manager

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.


Registration Fees

Early Registration
Registration Type Price By September 13, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839

Regular Registration
Registration Type Price After September 13, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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