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, 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