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Parenteral Drug Association Connecting People, Science and Regulation ®

Addressing Biofilm and Other Non-routine Microbial Events – New Course

Aug 02 - Aug 02, 2018 |
Aug 02, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

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 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.

Who Should Attend

This course will benefit supervisor or manager level attendees that are directly involved in non-routine microbial events and risk assessment activities.


Some college level understanding of microbiology and chemistry is preferred but not required of the attendees.

Upon completion of this course, you will be able to:

  • Evaluate contamination control best practices
  • Identify critical parameters for cleaning and disinfection
  • Define the critical elements of a risk-based approach
  • Describe the different steps in a risk-based flow diagram
  • Compare and contrast the different risk-based tools
  • Apply various risk-based approaches to real-world case studies to address non-routine events
  • Recall industry best practice for facility contamination control programs
  • Review parts, setup and operation of the EPA and ASTM high shear CDC biofilm reactor and single tube methods
  • Evaluate and discuss laboratory test results using the methods on single species biofilms under various conditions
  • Review critical factors in addressing a single or multi-species biofilm
  • Define holistic approaches to cleaning, rouge removal and microbial contamination remediation strategies



On or before June 18, 2018

After June 18, 2018


On or before June 18, 2018

After June 18, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 3, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Paul Lopolito, Sr. Manager, Technical Services, STERIS Corporation

Paul Lopolito is a senior technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently manages the Process and Cleaner Evaluation (PACE® Evaluation) program and provides global technical support related to process cleaning and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has specific expertise in managing cross-functional projects with over 20 years of experience. Paul has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events and has published numerous articles and book-chapters related to cleaning, cleaning validation and contamination control. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

Joe McCall, Technical Services Specialist, STERIS Life Sciences

Joe is a Technical Service Specialist with STERIS Life Sciences. He specializes in microbial control, environmental monitoring, contamination investigations and cleanroom issues. Joe has over 20 years of experience in the biopharmaceutical and medical device industries, specializing in aseptic processing, cleanroom qualification, environmental monitoring, and risk management. He is based in South Carolina USA and provides global technical support and expert consultation services for Critical Environments. Joe is an invited conference speaker on pharmaceutical microbiology topics at Pharmaceutical Microbiology Forum (PMF), PDA, A3P Belgium, ISCC, and course instructor at NIBRT Ireland and the University of Tennessee Health Science Center’s Aseptic Processing Training course. He is a vetted member of the US FDA’s Network of Experts program, an ASQ certified Six Sigma Green Belt, and is one of only 32 professional microbiologists globally to attain the American Society for Microbiology (ASM) certification as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #537 | ACPE #0116-0000-17-027-L04-P | 0.6 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.

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