Name: Medical Device Sterilization Workshop 2024
Start: 2024-09-24T00:00:00-05:00
End: 2024-09-25T18:00:00-05:00
Location: Tollestrup Auditorium

Medical Device Sterilization Workshop 2024

from Tuesday, 24 September 2024 (00:00) to Wednesday, 25 September 2024 (18:00)

Monday, 23 September 2024
Tuesday, 24 September 2024

08:00 Hybrid
Hybrid
08:00 - 12:05

Safety/Logistics
Safety/Logistics
08:00 - 08:05

08:05 Welcome - FNAL
Welcome - FNAL
08:05 - 08:10
08:10 Fermilab 101 - Thomas Kroc (Fermilab)
Fermilab 101
- Thomas Kroc (Fermilab)
08:10 - 08:40
A short description of what Fermilab is, its history, and its accomplishments.
08:40 Keynote - - Aftin Ross (Deputy Director - Office of Readiness and Response, Office of Strategic Partnerships & Technology Innovation, CDRH)
Keynote -
- Aftin Ross (Deputy Director - Office of Readiness and Response, Office of Strategic Partnerships & Technology Innovation, CDRH)
08:40 - 09:25
Aftin Ross, PhD Deputy Director - Office of Readiness and Response, Office of Strategic Partnerships & Technology Innovation, CDRH
09:25 Update from the TUV-SUD Scientific Echange - Vu Lekate (Abbott Vascular) Martell Winters (Nelson Labs) Mark Pasmore (Baxter) Jan Havel (TÜV-SÜD)
Update from the TUV-SUD Scientific Echange
- Vu Lekate (Abbott Vascular)
- Martell Winters (Nelson Labs)
- Mark Pasmore (Baxter)
- Jan Havel (TÜV-SÜD)
09:25 - 10:00
10:00 Coffee Break - 20 minutes
Coffee Break - 20 minutes
10:00 - 10:20
10:20 TIR 17 Update - Jami McClaren (Boston Scientific)
TIR 17 Update
- Jami McClaren (Boston Scientific)
10:20 - 10:50
10:50 Alternative Gasses Panel - Andrew Brinkdopke (Pureline) Juha Mattila (Steris AST) David Opie (Noxilizer) Tony Eisenhut (NovaSterilis)
Alternative Gasses Panel
- Andrew Brinkdopke (Pureline)
- Juha Mattila (Steris AST)
- David Opie (Noxilizer)
- Tony Eisenhut (NovaSterilis)
10:50 - 11:35
Chlorine Dioxide, Nitrogen Dioxide, Supercritical CO2, Vaporized Hydrogen Peroxide
11:35 UVC Techical Presentation - Fanny Poulon (Germitec) Lionel Pineau (Eurofins-Biotech-Germande)
UVC Techical Presentation
- Fanny Poulon (Germitec)
- Lionel Pineau (Eurofins-Biotech-Germande)
11:35 - 12:05
12:05 Morning Wrap-up & Close of Virtual Session
Morning Wrap-up & Close of Virtual Session
12:05 - 12:10

12:10 Lunch Break - 70 Minutes
Lunch Break - 70 Minutes
12:10 - 13:15

13:15 Hybrid
Hybrid
13:15 - 16:30
Alternative SAL - Martell Winters (Nelson Labs)
Alternative SAL
- Martell Winters (Nelson Labs)
13:15 - 13:45
13:45 What Does Max Dose Mean? - John Williams (Medtronic)
What Does Max Dose Mean?
- John Williams (Medtronic)
13:45 - 14:15
14:15 Parametric Release Panel - Juha Mattila (Steris AST) Mike Sadowski (Baxter) Nicholas Brydon (NextBeam)
Parametric Release Panel
- Juha Mattila (Steris AST)
- Mike Sadowski (Baxter)
- Nicholas Brydon (NextBeam)
14:15 - 15:00
15:00 Coffee Break - 30 minutes
Coffee Break - 30 minutes
15:00 - 15:30
15:30 Tem Nablo Update - Leo Fifield (PNNL)
Tem Nablo Update
- Leo Fifield (PNNL)
15:30 - 16:00
16:00 Dose Audits with Alternative Modalities - Zubrina Tumaitis (Sterigenics)
Dose Audits with Alternative Modalities
- Zubrina Tumaitis (Sterigenics)
16:00 - 16:30
16:30 Close of Day 1
Close of Day 1
16:30 - 16:40

17:30 No-host Social - Two-Brothers Roundhouse
No-host Social - Two-Brothers Roundhouse
17:30 - 20:30
Wednesday, 25 September 2024

08:30 Hybrid Session
Hybrid Session
08:30 - 11:55

Welcome - Day 1 recap
Welcome - Day 1 recap
08:30 - 08:45

08:45 International Panel
International Panel
08:45 - 09:40

09:40 FDA Agency Update
FDA Agency Update
09:40 - 10:25

10:25 Coffee Break - 20 Minutes
Coffee Break - 20 Minutes
10:25 - 10:55

10:55 Standards Development
Standards Development
10:55 - 11:25

11:25 UVC Regulatory Perspectives
UVC Regulatory Perspectives
11:25 - 11:55

11:55 Morning Wrap-up & Close of Virtual Session
Morning Wrap-up & Close of Virtual Session
11:55 - 12:00

12:00 Lunch Break - 60 Minutes
Lunch Break - 60 Minutes
12:00 - 13:00

13:00 Hybrid Session
Hybrid Session
13:00 - 16:30

Regulatory Affairs Panel
Regulatory Affairs Panel
13:00 - 13:40

13:40 Discussion - Collaborating w/ Kilmer/AAMI/PDA
Discussion - Collaborating w/ Kilmer/AAMI/PDA
13:40 - 14:20

14:20 Discussion - FDA - Panel
Discussion - FDA - Panel
14:20 - 15:00

15:00 Coffee Break - 20 Minutes
Coffee Break - 20 Minutes
15:00 - 15:20

15:20 Tours
Tours
15:20 - 16:30

16:30 Close of Workshop
Close of Workshop
16:30 - 16:40