Medical Device Sterilization 2022: From Possibilities to Practice
from
Wednesday, September 21, 2022 (8:30 AM)
to
Friday, September 23, 2022 (11:45 AM)
Monday, September 19, 2022
Tuesday, September 20, 2022
Wednesday, September 21, 2022
8:30 AM
Introductions
Introductions
8:30 AM - 8:45 AM
8:45 AM
Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization
Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization
8:45 AM - 9:30 AM
9:30 AM
TIR-104: A Case Study
TIR-104: A Case Study
9:30 AM - 10:00 AM
10:00 AM
Break
Break
10:00 AM - 10:15 AM
10:15 AM
Sterilization Conversions
Sterilization Conversions
10:15 AM - 10:45 AM
10:45 AM
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 AM - 11:45 AM
11:45 AM
End of Day Questions and Closing
End of Day Questions and Closing
11:45 AM - 12:00 PM
Thursday, September 22, 2022
8:30 AM
Recap Day 1 / Agenda Day 2
Recap Day 1 / Agenda Day 2
8:30 AM - 8:40 AM
8:40 AM
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
8:40 AM - 9:10 AM
9:10 AM
Break
Break
9:10 AM - 9:30 AM
9:30 AM
Mock Pre-Submission with FDA
Mock Pre-Submission with FDA
9:30 AM - 10:25 AM
10:25 AM
Break
Break
10:25 AM - 10:35 AM
10:35 AM
Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
10:35 AM - 11:30 AM
11:30 AM
End of day Questions and Closing
End of day Questions and Closing
11:30 AM - 12:00 PM
Friday, September 23, 2022
8:30 AM
Recap Day 2 / Agenda Day 3
Recap Day 2 / Agenda Day 3
8:30 AM - 8:40 AM
8:40 AM
Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing
Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing
8:40 AM - 9:10 AM
9:10 AM
Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools
Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools
9:10 AM - 9:40 AM
9:40 AM
Break
Break
9:40 AM - 10:00 AM
10:00 AM
Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package
Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package
10:00 AM - 10:30 AM
10:30 AM
Building Irradiators - Where Do We Go?
Building Irradiators - Where Do We Go?
10:30 AM - 11:15 AM
11:15 AM
End of Day Questions and Closing
End of Day Questions and Closing
11:15 AM - 11:45 AM