Conference sessions are comprised of technical papers, panels, and case studies on the latest issues impacting the industry. Get the most up-to-date information from leading industry experts in your fields. 

 Program subject to change. More session presentations will be added below as they are approved.

Monday, May 3, 2021

9:30 - 11 a.m. Central Time
Cleanroom Microbiology
Chair: Ziva Abraham

  • Live Networking
  • Particulate, Chemical & Microbial Contamination Control for Cleanrooms: A Comparative Assessment — Dr. Ramamurthy Nagarajan
  • Viral Safety of Cleaned Surfaces — Paul Lopolito, STERIS
  • Resistance of Microbes to Disinfection and Sterilization: Current Thinking and Trends — Ziva Abraham, Microrite, Inc.
  • Live Q&A with the Presenters


11:20 a.m. - 12:50 p.m. Central Time
Pass Throughs and Airlocks
Chair: Morgan Polen, Microrite

  • Live Networking
  • Pass-Throughs and Airlocks: Clearing up Misunderstandings related to Pass-throughs and Airlocks for Cleanrooms
  • International GMP Requirements for Pass-throughs: Mistakes Pharmaceutical Companies are Making by Installing Unsuitable Pass-throughs
  • Live Q&A with the Presenters


1:45 - 3:15 p.m. Central Time
Cleaning, Disinfecting, and Considerations for Facility Design in Sterile Compounding
Chair: Michael Myers, Contec

This three part session will focus on cleaning and disinfecting best practices in sterile compounding,  facility design considerations for sterile compounding pharmacies and special considerations for compounding Hazardous Drugs. This session will help attendees navigate the standards established by USP Chapters <797> and <800>. There will be time for Q&A with industry experts.

  • Live Networking
  • Patient Safety, With Focus on Microbial Contamination  — Abby Roth, CriticalPoint, LLC.
  • Designing Operationally Compliant Cleanrooms Drives Patient Safety — Adam West, CriticalPoint, LLC.
  • Decontamination of Hazardous Drugs — Mark Wiencek, Contec
  • Live Q&A with the Presenters

 

Tuesday, May 4, 2021

10:15 - 11:45 a.m. Central Time
Risk Assessment for Cleanrooms and Controlled Environments
Chair: Jan Eudy, Consultant

Risk assessments and management strategies are an integral part of a robust quality management system.An overview of what is risk management and how risk management strategies can be used across a wide range of Cleanrooms and cGMP problems will be presented as well as types of risk assessment methods.
 
  • Live Networking
  • Risk Management Basics — Jan Eudy, Consultant
  • Paper Compliance vs. Factual Risk Assessment — Ziva Abraham, Microrite, inc.
  • Common Risk Assessment Errors: Case Studies — Jaime Kaho’ohanohano, Microrite, Inc.
  • Live Q&A with the Presenters


1:30 - 3 p.m. Central Time
Gene and Cell Therapy
Chair: Anne Marie Dixon-Heathman, Cleanroom Management Associates, Inc.

  • Live Networking
  • Environmental Monitoring System Design, Commissioning, and Validation for Cell and Gene Therapy Laboratories — Hasim Solmaz, Lighthouse Worldwide Solutions
  • A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom  — Jim Polarine, STERIS
  • Mitigating Risks through the Use of Single-Use Products & Technologies — John Batts, Cole-Parmer
  • Live Q&A with the Presenters
     

Wednesday, May 5, 2021

11:00 a.m. - 12:30 p.m. Central Time
Contamination Control in Cleanrooms
Chair: Jim Polarine, STERIS

This session will cover how contamination in cleanrooms can affect control and product sterility in cleanroom operations.  Common sources of cleanroom contamination can come from raw materials, poor gowning practices, operator behavior, aging facilities, and items brought into the cleanroom.  This session will cover case studies in contamination control in pharmaceutical, biotech, and medical device cleanrooms.  Risk assessments and CAPA investigations will be covered that relate directly to improving contamination control programs. Procedures will be covered to proactively prevent future product sterility failures and large-scale contamination events. This seminar will benefit non-sterile and sterile manufacturers.

  • Live Networking
  • Advanced Aseptic Processing Technologies – Robotics for Filling of Sterile Medicines — Joseph McCall, ADMA Biologics
  • Understanding the Outcomes of Disinfectant Testing — Dan Klein, STERIS Corporation
  • Study of Fallout Metrics for Contamination Analysis: Vertical to Horizontal Particle Accumulation Ratio — Elaine Stewart, NASA
  • Live Q&A with the Presenters


2 - 3:30 p.m. Central Time
Contamination Control in the Cannabis Market
Chair: Jim Polarine, STERIS

The idea of contamination control in the Cannabis market may seem unimportant since when cannabis is grown properly with organic fertilizers, no pesticides, and dried in a clean environment, it is generally safe for consumption. Cannabis is, after all, not cultivated in a microbial free environment. The issue is when companies expand into large-scale manufacturing operations, it’s imperative to control and test for potentially harmful organisms and pesticides to ensure a Quality product. Social pressures for safe, quality, efficacious, consistent cannabis is placing a growing demand for lab tests to ensure the safety not only of medicinal marijuana, but recreational cannabis as well. In this rapidly developing market, regulations specific for this segment have been lagging behind until recently when both in Canada and the US, strict guidelines have been imposed on the industry to ensure the final product does not contain significant levels of harmful substances. This session will cover how contamination in the cannabis market can affect control and product quality.  Common sources of contamination can come from raw materials, poor gowning practices, operator behavior, rapidly expanding facilities or not fit for size and purpose, and items brought into the facility.  This session will cover the history of the cannabis market, contamination control in the cannabis cultivation and extraction processes, and ways to improve control and production in the cannabis market.

  • Live Networking
  • Cleaning Validation and Contamination Control for Cannabis Cultivators and Manufacturers: Best Practices for Ensuring Patient and Consumer Safety — Beth Kroeger, STERIS
  • The Importance of Obtaining an Accurate Microbial Identification for Contamination Control — Christine Farrance, Charles River Laboratories
  • Live Q&A with the Presenters

 

Thursday, May 6, 2021


9:45 a.m. - 11:15 a.m. Central Time
Guide to Cleanroom Consumables
Chair: Mike Rataj, Aramark Cleanroom Services

  • Live Networking
  • Thermal Comfort of Cleanroom Users: Onsite Investigation and Methods for Improvements — Katerina Roskotova, University Centre for Energy Efficient
    Buildings, Czech Technical University
  • Gear Up with Flame Resistant Face Masks — Dalia Taylor, DuPont
  • Comparisons between Cleanroom Apparel and Medical PPE — Steve Glosson, Precision Fabrics Group
  • Live Q&A with the Presenters


11:30 a.m. - 1:00 p.m. Central Time
Best Practices for Data Centers

Co-Presenter: Jason Roth, Sterile Environment Technologies
Co-Presenter: Terry Munson, Foresite, Inc.


Data centers are considered an ISO 8 environment by ASHRAE and ISA, however are not always built like a normal Cleanroom. So this creates discrepancies on maintenance and problematic corrosion. Best practices on how to approach this for your data center will be discusses.

  • Live Networking
  • Live Q&A with the Presenter
     

1:30 p.m. - 3:00 p.m. Central Time
Roundtable Discussion: Common Contamination Control Mistakes and How to Avoid Them Though Practical Best Practices
Chair: Dave Nobile, Contec

Listen-in as a panel of contamination control and industry experts discuss contamination control mistakes observed in cleanrooms worldwide, how to avoid them, and how to achieve practical best practices for any given facility. Then join the conversation with your own contamination control questions or problems, and get actionable answers from multiple perspectives.

  • Live Networking
  • Live Q&A with the Presenters

To submit an abstract for one of the above topics, please click here.

 

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