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Contamination Control – Develop and Implement a Risk-based Program

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Implement a Risk-based Program for Normal and Pandemic Operations

May 6

Virtual, United States

Bio/pharmaceutical companies spend and exorbitant amount of time and money on contamination control, disinfection, testing methods, innovative technologies, analytical methods, environment monitoring and data trending. KENX is proud to present this virtual training that help you master the innovative processes, techniques and compliance trends to make an immediate impact in your organization. In the era of the COVID 19 pandemic, the time has never been greater to ensure your personnel is safe, PPE are available and used properly and contaminants are controlled effectively.

 

Top Reasons to Attend

  1. Risk Management – Assess, Identify and Evaluate Risk
  2. Microbial Control – Develop a Proactive Strategy to Reduce Risk
  3. Clean-by-Design – Implement a Risk-Based Approach to Contamination Control
  4. Disinfectant Efficacy – Create a Training Strategy Playbook for Operators
  5. Human Behavior – Know the Impact and Reduce Risk
  6. Production Equipment – Validate a Decontamination System
  7. Preventive Measures – Identify Sources and Prevent Contamination
  8. Environmental Monitoring – Build an Effective Program and Master Data Trending
  9. Remote Validation – Validate Equipment Hands Free
  10. Derouging and Passivation – Learn a Total Predictive Maintenance Approach

 

Agenda

  • 10:45 AM EST
    Webinar Host Opening Remarks
    Howard Wilensky, Executive Director, KENX
  • 11:00 AM – 12:30 PM EST
    Implement a Risk-based Contamination Control Strategy
    David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
  • 12:30 – 12:45 PM EST
    Break
  • 12:45 – 2:15 PM EST
    Cleaning and Disinfection of Cleanrooms – Keeping Products Safe
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi Pasteur
  • 2:15 – 2:30 PM EST
    Break
  • 2:30 – 4:00 PM EST
    Overcome Challenges in Cleaning and Maintaining Stainless Steel Equipment
    Beth Kroeger, Technical Services Senior Manager, STERIS Life Sciences
  • 4:00 – 4:15 PM EST
    Break
  • 4:15 – 5:45 PM EST
    How Technology Ensures Business Continuity, Improves Efficiency, and Reduces Contamination Exposure
    Steve Thompson, Director Industry Solutions, ValGenesis
  • 5:45 PM EST
    Close of Virtual Training

Faculty

  • Beth Kroeger, Technical Services Manager, STERIS Life Sciences

    Beth Kroeger is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and the National Institute for Bioprocessing Research and Training.
  • David W. Vincent, CEO, MPH, PhD, VTI Life Science

    David Vincent has over thirty-two (32) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, B.Sc., Mechanical Engineering Technology, Master and PhD in Public Health. He is especially strong in the areas of Process Development and Validation, Cleanroom design and management as well as developing and implementing Aseptic and Environmental Monitoring Programs.
  • Steven Thompson, Director Industry Solutions, VALGENESIS

    Steve has worked in Life Sciences for over 20 years, has a Bachelor of Science degree in Computer Information Systems, served in both technical and quality roles. He’s a PDA certified auditor, has audited hundreds of companies globally, is a published author, and frequent speaker at conferences. Currently he’s Director of Industry Solutions for ValGenesis, Inc. (valgenesis.com)
  • Dawn Tavalsky, Senior Director of Global Quality, Sanofi

    Ms. Tavalsky is a Senior Director of Global Quality with Sanofi Pasteur, the vaccine division of Sanofi. She has over 30 years of experience in the pharmaceutical industry including small molecule, device, biologics and vaccines. She is a Sterility Assurance and Validation subject matter expert.

Sponsors

  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/

Venue

Details

Date:
May 6
Event Category:

Venue

Remote
Virtual, United States

Pricing & Registration

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