CONTAMINATION CONTROL/NANO CONFERENCE SESSIONS


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

Description coming soon.

  • Live Networking
  • Particulate, Chemical & Microbial Contamination Control for Cleanrooms: A Comparative Assessment — Dr. Ramamurthy Nagarajan
  • Live Q&A with the Presenters


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

Description coming soon.

  • Live Networking
  • 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
  • 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.
  • Supply Chain Management During Pandemics — Firooz Taleghani, Korea Aerospace Industries
  • 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.

Description coming soon.

  • 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
  • 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
  • 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
  • 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

Description coming soon.

  • Live Networking
  • Live Q&A with the Presenters


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

Presenter: Jason Roth, Sterile Environment Technologies

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
Chair: Dave Nobile, Contec

Description coming soon.

  • 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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