Medical Device Sterilization 2022: From Possibilities to Practice
from
Wednesday, 21 September 2022 (08:30)
to
Friday, 23 September 2022 (11:45)
Monday, 19 September 2022
Tuesday, 20 September 2022
Wednesday, 21 September 2022
08:30
Introductions
Introductions
08:30 - 08:45
08:45
Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization
Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization
08:45 - 09:30
09:30
TIR-104: A Case Study
TIR-104: A Case Study
09:30 - 10:00
10:00
Break
Break
10:00 - 10:15
10:15
Sterilization Conversions
Sterilization Conversions
10:15 - 10:45
10:45
Driving a “One Voice” Bioprocess Approach to Qualify X-ray as an Equivalent Alternative to Gamma
Driving a “One Voice” Bioprocess Approach to Qualify X-ray as an Equivalent Alternative to Gamma
10:45 - 11:45
11:45
End of Day Questions and Closing
End of Day Questions and Closing
11:45 - 12:00
Thursday, 22 September 2022
08:30
Recap Day 1 / Agenda Day 2
Recap Day 1 / Agenda Day 2
08:30 - 08:40
08:40
A Practical Approach to Establishing a 2x Process for E-Beam Sterilization of Medical Devices
A Practical Approach to Establishing a 2x Process for E-Beam Sterilization of Medical Devices
08:40 - 09:10
09:10
Break
Break
09:10 - 09:30
09:30
Mock Pre-Submission with FDA
Mock Pre-Submission with FDA
09:30 - 10:25
10:25
Break
Break
10:25 - 10:35
10:35
Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
10:35 - 11:30
11:30
End of day Questions and Closing
End of day Questions and Closing
11:30 - 12:00
Friday, 23 September 2022
08:30
Recap Day 2 / Agenda Day 3
Recap Day 2 / Agenda Day 3
08:30 - 08:40
08:40
Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing
Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing
08:40 - 09:10
09:10
Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools
Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools
09:10 - 09:40
09:40
Break
Break
09:40 - 10:00
10:00
Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package
Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package
10:00 - 10:30
10:30
Building Irradiators - Where Do We Go?
Building Irradiators - Where Do We Go?
10:30 - 11:15
11:15
End of Day Questions and Closing
End of Day Questions and Closing
11:15 - 11:45