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CLEANROOM VALIDATION, DISINFECTION AND ENVIRONMENTAL MONITORING

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February 17, 2020 - February 19, 2020

San Diego, United States

Many companies have spent an exorbitant amount of money and time on the qualification of cleanrooms and the validation of product manufactured within. KENX is proud to present a one-stop-shop for professionals tasked with the contamination control, cleanroom design and cleaning validation practices at their facility. This conference showcases those paving the way in best practices in cleaning validation, cleanroom qualification, disinfection, contamination control, environmental monitoring and more. This conference delivers more the 30 tutorials in:

 

Cleaning Validation & Critical Cleaning Processes

  • Implement a Risk-based Program
  • Set Acceptance Criteria and Health Limits
  • Determine Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
  • Implement a Continuous Monitoring Program

 

Cleanroom Validation and Qualification

  • Ensure state of control through airflow quality
  • Determine what tests need to be performed
  • Implement IQ/OQ/PQ Protocols
  • See the latest aseptic technologies and best practice

 

Contamination Control & Disinfection

  • Understand the regulations and develop a strategy
  • Design a process for effective residue removal
  • Identify contamination risks and conduct an assessment
  • Reduce validation timelines and cost

 

Environmental Monitoring

  • Determine types of sampling performed and implement a strategy
  • Trend data and analyze results
  • Understand the key components a summary report
  • Monitor viable and non-viable particles

 

Agenda

  • 12:00
    Conference Registration
  • 1:15
    Cleanroom Specifications – Understand the Pending Impact of EU GMP Annex 1
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 2:15
    Sterilization and Cleaning Validation - Inspections, Warning Letters and Trends
    Beth Kroeger, Technical Services Manager, STERIS Life Sciences
  • 3:00
    Networking Refreshment Break
  • 3:30
    Microbial Control – Developing a Proactive Strategy to Reduce Risk
    Cindy Duhigg, Global Validation Steward, Alcon Laboratories
  • 4:15
    Understand the Impact of Human Behavior in Sterile Environments
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 5:00
    Temple University Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Sessions (1-2)
  • 1
    Audit Cleaning and Disinfectant Suppliers on Validation and Compliance
    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
  • 2
    Clean On Demand – A Paradigm Shift in Early Phase GMP Manufacturing
    Ravi Samavedam, President, Cleanrooms On Demand, Azzur Group LLC.
  • 8:30 - 10:00
    Select Between Execution and Master Planning Workshops (3-4)
  • 3
    Develop a Risk-Based Approach to Contamination Control
    Cindy Duhigg, Global Validation Steward, Alcon
  • 4
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 - 12:00
    Select Between Execution and Master Planning Workshops (5-6)
  • 5
    Disinfectant Efficacy – Development and Validation
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 6
    Design, Qualify and Maintain Isolator Technology in Aseptic Processing
    Joe Cagnassola, Principal Validation Engineer, Alcon
  • 12:00
    Networking Luncheon or Grab & Go Lunch & Learn
  • Setting Critical Cleaning Process Parameters and Critical Quality Attributes
    Keith Bader, VP of Cleaning Science and Technology, Research Scientist, Hyde Engineering + Consulting
  • 1:15 - 2:45
    Select Between Knowledge Exchange Sessions (7-8)
  • 7
    Implement a Risk-Based Environmental Monitoring Program
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • 8
    Validation of Disinfectant Efficacy Studies for Cleanroom Environments
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 2:45
    Afternoon Refreshment Break
  • 3:15 - 4:45
    Select Between Knowledge Exchange Sessions (9-10)
  • 9
    Learn How to Conduct Visual Inspection
    Igor Gorsky, Senior Consultant, ValSource
  • 10
    Establishing Acceptance Criteria for Cleaning Validation
    Fred Ohsiek, Senior Cleaning Validation Specialist, Novo Nordisk
  • 4:45
    Closing Session
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Breakfasts (11-12)
  • 11
    Create a Training Strategy Playbook for Operators in Cleaning and Disinfection
    Dawn Tavalsky, Senior Director and Sterility Assurance SME, Sanofi
  • 12
    Develop a Risk-Based Approach to Control Residues
    Fred Ohsiek, Senior Specialist Cleaning Validation, Novo Nordisk
  • 8:30 - 10:00
    Select Between Knowledge Exchange Sessions (13-14)
  • 13
    Lifecycle Management of Analytical Methods for Cleaning Verification Support
    Mariann Neverovitch, Cleaning Validation SME, Bristol Myers Squibb
  • 14
    Environmental Monitoring Data Trending and Analysis
    Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 - 12:00
    Select Between Knowledge Exchange Sessions (15-16)
  • 15
    Case Studies in Contamination Control
    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
  • 16
    Training Personnel in Sterile Environments - A Microbiological Perspective
    Erin Thane, VP and Partner, Azzur Labs
  • 12:00
    Networking Luncheon or Grab & Go Lunch & Learn
  • Qualify Water Systems, Clean Steam and Process Gasses
    Cindy Duhigg, Global Validation Steward, Alcon
  • 1:15 - 2:45
    Select Between Knowledge Exchange Sessions (17-18)
  • 17
    Maintaining Your Stainless Steel Equipment in Sterile Environments
    Beth Kroeger, Technical Services Manager, STERIS Life Sciences
  • 18
    Disinfectant Residues – Defining a Visual Standard
    David Keen, Senior Global Microbiologist, Ecolab Life Sciences
  • 2:30
    Afternoon Refreshment Break
  • 3:00 - 4:30
    Select Between Knowledge Exchange Sessions (19-20)
  • 19
    Contamination Control Strategies for Non-Sterile Environments
    Joscelyn Bowersock, Quality and Regulatory Manager, Carolina BioOncology Institute
  • 20
    Determine Optimal Sampling Sites in Cleanrooms
    Igor Gorsky, Senior Consultant, ValSource
  • 4:30
    Close of Conference

Faculty

    More Information To Follow Soon

Sponsors


  • A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
    Website: https://www.azzur.com/

  • 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/

  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

  • RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years

    Website: http://www.temple.edu/pharmacy_qara

Partners

    More Information To Follow Soon

Venue

Details

Start:
February 17, 2020
End:
February 19, 2020
Event Category:

Venue

The Dana on Mission Bay
1710 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(619) 222-6440
Website:
https://www.thedana.com/‎

Pricing & Registration

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