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Medical Device Sterilization 2022: From Possibilities to Practice

US/Central
Virtual
Thomas Kroc (FNAL)
Description

Join us and your peers to continue the dialog on medical device sterilization science and take a deeper dive to understand how to utilize new radiation modalities.

Overview: On September 21, 22, and 23, 2022 the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation. 

The workshops will run from:

  • 8:30 am CDT to 12:00 pm - Wednesday, September 21st
  • 8:30 am CDT to 12:00 pm - Thursday, September 22nd 
  • 8:30 am CDT to 11:45 pm - Friday, September 23rd 

REGISTRATION DEADLINE: September 7, 2022

Over three half-days, the workshop will build on the work presented in the past three years (summary reports) and work towards fostering collaboration and partnership under the common goal of patient safety:

  • A mock Pre-submission interaction with the FDA

  • Emerging modeling and simulation tools to help you better utilize radiation on your products.

  • A panel discussion with members from the bio-processing industry illustrating how industry cooperation can smooth the regulatory process

  • There will be multiple Q&A opportunities to provide interaction and to allow you to present your experiences and confront your uncertainties.

Connection information will be e-mailed to registrants 24 hours prior to the event.

Invited Speakers

Keynote presentation – Aftin Ross (FDA), confirmed

  • Ryan Ortega, FDA – leading the Mock Pre-submission, confirmed
  • PNNL/Team Nablo
  • Vu Le, Abbott
  • James McCoy, BD
  • Daniel Badali, Triple Ring Technologies
  • TRAD

Organizing Committee

  • Debbie Cotton (Retired)
  • Thomas Kroc (Fermilab)
  • Vu Le (Abbott)
  • Mark Pasmore (Baxter)
  • John Williams (Medtronic)

Who should attend: Recent events in the medical device sterilization community reinforce that patient safety, in particular sterility assurance, is not specific to any particular company, vendor, or institution.  This forum seeks to bring together voices from across these various organizations to define and build the future of this industry, for the benefit of the patients we serve. Participants from technical, business, and regulatory functions from the following organization types will benefit from workshop participation:

  • Medical device manufacturers
  • Accelerator manufacturers
  • Contract sterilization vendors
  • Medical device regulators
  • Medical device regulatory
  • Medical device and sterilization laboratories

Attendees should expect to:

  • Examine the current science of radiation sterilization techniques (X-ray, gamma, and E-beam)
  • Maintain connection with developments in the use of alternative technologies for medical device sterilization
  • Influence discussion on the direction of medical device sterilization and potential collaboration opportunities and mechanisms to help realize that future
  • Interact with staff of the FDA to better understand how to work with the FDA for approvals for new and existing products
Participants
  • *Andrew* *klein*
  • Aaron Sauers
  • Abbas Nasreddine
  • ADAM WHAITES
  • Adriana Uranga
  • Aftin Ross
  • Ainhoa Grau
  • Alandrea Cox
  • Albert Ortega
  • Alejandra Munoz
  • Alma Garcia
  • Amira ZAOUAK
  • Amitkumar Suthar
  • Amy Freel
  • Ana Martinez
  • Andrew Porteous
  • Andy DEsposito
  • Angela Brightwell
  • anissa laffont
  • Annemie Rehor Kausch
  • Anthony Cain
  • Anthony Piotrkowski
  • Antoine GHILARDI
  • Aric Meinerts
  • Arnaud Henry
  • Arnaud Pierard
  • Ashley Lemire
  • Barbra Naigaga
  • Bart Croonenborghs
  • BEATRIZ MARIN
  • Beau Rollins
  • Benjamin Larson
  • Berivan Hamoto
  • Beth Marquez
  • Betty Howard
  • Bill Brodbeck
  • Bill Facemire
  • Björn Wiese
  • Blake Hawkinson
  • Brandon DellAringa
  • Brenda Simons
  • Brian Whitaker
  • Briana Potocnik
  • Byron Lambert
  • Carl Weitzmann
  • Carla Konzel
  • Carmen Asbun
  • Carmen Reyes
  • Chad Rhodes
  • Cherri Schmidt
  • CHIK LIANG OOI
  • Chip Starns
  • Chris Edwards
  • Christiane Beerlage
  • Christiane Rosefort
  • Christopher Dugard
  • Christopher Ferguson
  • Christopher Merton
  • Ciara macsweeney
  • Clarence Murray III
  • Cody Wilson
  • Colin Wang
  • curtis allen
  • D Thomas
  • Daianna Carrasco
  • Damien Prieels
  • Daniel Badali
  • Daniel Elpidio Rodriguez Bello
  • Daniel Longhorn
  • Daniel Payne
  • Daniel Wojtczak
  • Dave Adams
  • Dave Miller
  • Davi Waltz
  • David Moore
  • David Rechberger
  • Dawn Marshall
  • Debbie Cotton
  • Deborah Havlik
  • Deepak Namdev
  • Deepak Patil
  • Denise Cleghorn
  • Diana Smith
  • Dimitri Dermatis
  • Dominique Vincent
  • Eanna Burke
  • Edmarie Mendez-Laguna
  • Edmund Orr
  • Eileen Henley
  • Elisabetta Zanella
  • Elizabeth Claverie
  • Emily Cardona
  • Emily Waller
  • Emma Sliwak
  • Emre Güllüoğlu
  • Eric Beers
  • Eric Crawley
  • Eric Laingen
  • Eric Meissner
  • Eric Peryer
  • Erin Koh
  • Estibaliz Arcaraz
  • Filippos Toufexis
  • FLORENT KUNTZ
  • Fran Wayne
  • Frank Flores
  • Frederic Dessy
  • Gabriel Honorio
  • Gail Dyer
  • Gary Harris
  • Giorgia Bresciani
  • Glenn Calvert
  • Gregory OBrien
  • Günther Burgstaller
  • Haikel JELASSI
  • Hakan Behcan
  • Haoming Rong
  • Harpreet Kaur
  • Harry Lam
  • Helena Jeppsson
  • Huseyin Kanbur
  • Ilia Geltser
  • Isabelle Arts
  • Isabelle Szot
  • Ivannia Jiménez
  • J. Charles Thangaraj
  • Jackie Somadelis
  • Jade Schiesser
  • Jake Gibbons
  • James Hathcock
  • James McCoy
  • Jane Pretkelis
  • Jared Tinker
  • Jason Canaway
  • jason hedrick
  • Jeff Cook
  • Jeffrey Reed
  • Jenna Eicherly
  • Jeremy Brison
  • Jerome Henry
  • Jesse Seidman
  • Jessica Garigen
  • Jessica Goerdt
  • Jessica Harvey
  • Jim Maher
  • Jim Natzel
  • John Chen
  • John Reilly
  • John Williams
  • Jon Jansson
  • Jon Lee
  • Jordan Fujioka
  • Jose Hugo Barajas
  • Josef Mittendorfer
  • Joseph Koenigsman
  • Joseph Wolinski
  • Joshua Bowen
  • JUAN ZUNIGA
  • Jun Boneschansker
  • Justin Daller
  • Justin Tettenborn
  • Ka Lia Xiong
  • Kate Ager
  • Kate Davenport
  • Kathy Lane
  • Katie Schindler
  • Keith Swajger
  • Ken Wong
  • Kendall Horst
  • Kieran Murray
  • Kieyfer Damasio
  • Kimberly Patton
  • Krismelys Castillo
  • Kristen Bozzelli
  • Kristin Koscher
  • Kurt Housh
  • Kyrstan Polaski
  • laetitia tramcourt
  • Larry Nichols
  • Laura Wahlen
  • Lauren Specchio
  • Leah MacKrell
  • Leo Fifield
  • Leon Cakan
  • Leon Smidt
  • Leticia Rivera
  • Liliane Phan
  • Lindsey McGowan
  • Lingmei Li
  • Linh Lollis
  • Liv Arnold
  • Lorena Lopez
  • Lorenzo Pedrazzini
  • Lou Stinson
  • Louis Filiano
  • Lucia Polakova
  • Ludovic EYCHENNE
  • Lydia Nguyen
  • Macario Moreno
  • Magdalena Pierzchala
  • Makhtar Diallo
  • Mandeep Pathania
  • Mara Senescu
  • Marc Weimer
  • Marco Cardenas-Carmona
  • Maria Bollensen
  • MARIA GARMENDIA HARO
  • Maria Ruiz
  • Marine Thuret
  • Mark Bogs
  • Mark LeGarda
  • Mark Murphy
  • Mark Pasmore
  • Mark Simpson
  • Marlenis sanchez
  • Matthew Hammond
  • Matthew Keskula
  • Matthew McCoy
  • Matthew Preston
  • Mauricio Suarez
  • Max Blomberg
  • Meenakshi Verma
  • Megan Boyle
  • Mehmet Yalcintas
  • Meiyu Mao
  • MESFIN MENGESHA
  • Michael Chen
  • michael fletcher
  • Michael Lorenz
  • Michael Parker
  • Michelle (Shelly) Luebke
  • Miguel Morales
  • Mike Flanagan
  • Mike Neilson
  • Mike Rust
  • Mike Sadowski
  • Mohit Gupta
  • Molly Swanson
  • Moshe Cohen
  • Nan Silverman-Wise
  • Nancy Gonzalez
  • Nathan Meyer
  • Nazarena Ciávaro
  • Neal Feldhahn
  • Nicholas Brydon
  • Nicholas Shoop
  • Nicolas Ludwig
  • Nirmal Pol
  • Norman Link
  • ofir siletzky
  • Or Kol
  • Palash Das
  • Patric Klotzbuecher
  • Patrick Anibaldi
  • Paul Boentges
  • Paul Priebe
  • Paul Straka
  • Paul Wynne
  • Peter Baker
  • Peter Laurence
  • Peter Laurence
  • Peter Noverini
  • Phia Lee
  • Philippe Dethier
  • Ping Wang
  • Preeti Chopra
  • Rafael Rodriguez
  • Ram Dhuley
  • Randolph Schwarz
  • Remya S
  • Revanth Soma
  • Ricardo Alberto Mendez Flores
  • Richard Kanyenye
  • Richard Sparano
  • Rick Cannon
  • Rishabh Jain
  • robert huffman
  • Robert Smith
  • roger snyder
  • RUBEN GALINDO
  • Russell Mills
  • Ruth Davila Sanchez
  • Ryan Ortega
  • Samuel Dorey
  • Samuel Kikandi
  • Scott Hall
  • Seb Doheny
  • Sebastiano De Cesari
  • Seema Verma
  • Seema Verma
  • Shannon Bellak
  • Shari Formica
  • Sharon Lunney
  • Shaun Devitt
  • Shaun McGinley
  • Simone Rossi
  • Sonia Schwantes
  • Sopheak Srun
  • Sophie ROUIF
  • Soumaya Hammami
  • Spencer Mickum
  • Sreekanth Gutala
  • Stacy Wiehle
  • Stanislav Proskin
  • Stefano Pellegrini
  • Stephanie Volk
  • Stephen Anisko
  • Stephen Sadler
  • Stephen Sugden
  • Steven Elliott
  • Subrota Paul
  • Susan Mickens
  • Susan Perlman
  • Suzanne Butler
  • Syedah Jafary
  • Sébastien Masson
  • Teck Min Wong
  • Thibault Poinsot
  • Thomas Fenwick
  • Thomas Kroc
  • Thomas Oliver
  • Tim Thompson
  • Timo Neumann
  • Timothy Byland
  • Timothy Tiernan
  • Tobias Funk
  • TODD GABELE
  • Tomas Buryska
  • Tome Kraljevski
  • Trent Teeples
  • Trisha Pankratz
  • Tugba Gunaydi
  • Valeriia Starovoitova
  • Vartika Agarwal
  • VIJAI SANKAR
  • Vincent Bartoletti
  • vu le
  • Wayne Usher
  • Wenwen Su
  • Wesley Hare
  • William Jeschke
  • Xiao He
  • Ying Zhang
  • Yoko Parker
  • YVES HENON
  • Zach Dukerich
  • Zachary Deziel
Event Organizer: Tom Kroc
    • Welcome: Introductions
      Conveners: Mark Pasmore (Baxter), Roger Snyder (DOE)
    • Keynote: Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization
      Convener: Aftin Ross (FDA)
    • Presentation: TIR-104: A Case Study
      Convener: James McCoy (Becton Dickinson & Company)
    • 10:00 AM
      Break
    • Presentation: Sterilization Conversions
      Convener: Mark Bogs (ICU Medical)
    • Panel: Driving a “One Voice” Bioprocess Approach to Qualify X-ray as an Equivalent Alternative to Gamma
      Conveners: James Hathcock (Pall Biotech), Ken Wong (SanoFi), Matt Hammond (Amgen), Ping Wang (Janssen Pharmaceutical), Thomas Kroc (FNAL), Timo Neuman (Merck-Millipore)
    • Closing: End of Day Questions and Closing
      Convener: Mark Pasmore (Baxter)
    • Welcome: Recap Day 1 / Agenda Day 2
      Convener: Debbie Cotton
    • Presentation: A Practical Approach to Establishing a 2x Process for E-Beam Sterilization of Medical Devices
      Convener: Eric Crawley (Abbott)
    • 9:10 AM
      Break
    • Panel: Mock Pre-Submission with FDA
      Conveners: Christopher Dugard (FDA), Clarence Murray (FDA), Kristen Bozzelli (Baxter), Mark Pasmore (Baxter), Patrick Anibaldi (Abbott), Ryan Ortega (FDA), Sreekanth Gutala (FDA), Stephen Anisko (FDA)
    • 10:25 AM
      Break
    • Panel: Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
      Conveners: Christopher Dugard (FDA), Clarence Murray (FDA), Kristen Bozzelli (Baxter), Mark Pasmore (Baxter), Patrick Anibaldi (Abbott), Ryan Ortega (FDA), Sreekanth Gutala (FDA), Stephen Anisko (FDA)
    • Closing: End of day Questions and Closing
      Convener: Debbie Cotton
    • Welcome: Recap Day 2 / Agenda Day 3
      Convener: Thomas Kroc (FNAL)
    • Presentation: Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing
      Conveners: Ludovic Eychenne (Trad), Samuel Dorey (Sartorius)
    • Presentation: Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools
      Convener: Daniel Badali (Triple Ring Technologies, Inc)
    • 9:40 AM
      Break
    • Presentation: Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package
      Conveners: Leo Fifield (Pacific Northwest National Laboratory), Randy Schwarz (Pacific Northwest National Laboratory)
    • Panel: Building Irradiators - Where Do We Go?
      Conveners: Chad Rhodes (Sterigenics), Cody Wilson (IBA Group), Eric Beers (Steris), Jason Canaway (Steris), John Williams (Medtronic), Larry Nichols (Steri-Tek), Vu Le (Abbott)
    • Closing: End of Day Questions and Closing
      Convener: Thomas Kroc (FNAL)