TechTalk: Introduction to the Radiation Sterilization Master File Pilot Program
STERIS is the first participant in the FDA’s new Radiation Sterilization Master File Pilot Program, which expedites the approval process for refining sterilization methods of single-use medical devices.
This improves supply chain adaptability, mitigating potential roadblocks that might otherwise cause a supply chain shortage or hinder innovation.
In this seminar, learn eligibility requirements, the intricacies of different radiation sterilization modalities, and how STERIS guides Customers throughout the entire process.
30.58
Gamma Irradiation
Radiation ProcessingX-Ray
Webinar Overview
PROGRAM INTRODUCTION
Steve Elliott, Senior Manager of Regulatory Affairs
2:09 – Device Master File
3:08 – Master File Pilot Programs
4:21 – Supply Chain Continuity
5:18 – Eligible Changes
6:05 – Benefits of Participation
7:02 – Eligible Medical Devices
8:16 – Non-eligible Medical Devices
10:34 – Customer Product Evaluation Attestation
TECHNOLOGY OVERVIEW
Deepak Patil, Senior Director of Radiation Technology
12:18 – Photons & Electrons
15:32 – Technology Comparison
17:19 – Dose is Dose
18:57 – Modality Transfer
20:38 – Resources (TechTalk – http://bit.ly/4a6YlRC)
PILOT PROGRAM IMPLEMENTATION
Michael Ezzo, Senior Director of Quality and Regulatory Compliance
21:59 – How Can Customers Coordinate with STERIS?
26:01 – Implementing a Sterilization Process Change
26:48 – Do MAF Validations Differ from Previous Validations?
28:48 – Process Oversight
