Name: Medical Device Sterilization 2022: From Possibilities to Practice
Start: 2022-09-21T08:30:00-05:00
End: 2022-09-23T11:45:00-05:00
Location: No location set

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