Cleaning Sterilisation Processes
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Cleaning Sterilisation Processes
April 25, 2023 @ 9:30 am - April 26, 2023 @ 5:00 pm
25th-26th April 2023 at DGI Byen Conference Center, Copenhagen
A collaboration between ValidEire ApS and Key2Compliance
SUMMIT DESCRIPTION
Cleaning and Sterilization processes related to production equipment need to meet the standards of the authorities where the control and reduction of chemical, microbial, particulate and endotoxin/pyrogen contamination is considered important. Any contamination control strategy requires an evaluation of these controls based on risk and risk assessment.
Whether you work with Pharmaceuticals or Medical Devices, you are witness to a raised focus in respect to Cleaning and Sterilization processes. This 2-day summit in Copenhagen, Denmark brings Cleaning and Sterilization processes to you with multiple expert competences, including Quality Assurance experts, Global Task Force Standard contributors, and high-level consultants. And on top of this, you will have the opportunity to link up and network with industry peers.
WHO IS THE SUMMIT RELEVANT FOR?
Whether you or your team works with Quality Assurance, Quality Control, development, Validation or production related to Cleaning and Sterilization processes, this summit will add value to your team in multiple ways: You could work as eg. Manager, Chemist, Production Supporter, QC, RA, …
AGENDA
| Day 1 – 25th April, 2023 | Day 2 – 26th April, 2023 |
| 09:30-10:15 Laurent Merli Why a robust cleaning process before is essential for the success of the Sterilization one? |
09:00-09:45 Joe Cagnassola Creating a robust Cleaning Protocol and Report |
| 10:15-11:00 Susan B. Cleary Risk-Based Cleaning Validation, Carry Over and Process Automation |
09:45-10:30 Mark Thompson Top 10 inspection findings associated with Sterilization and Depyrogenation Processes |
| 11:00-11:30 Coffee, tea and snacks Exibition open |
10:30-11:00 Coffee, tea and snacks Exibition open |
| 11:30-12:15 Kenneth Farrugia Sustainable Cleaning Validation |
11:00-11:45 Igor Gorsky Use of statistics including treatment of censored data in Lifecycle Cleaning Validation as prescribed by ASTM E3106 |
| 12:15-13:15 Lunch | 11:45-12:45 Lunch |
| 13:15-14:00 Walid El Azab Case studies on common cleaning mistakes and enablers for cleaning improvement |
12:45-13:30 Solenn Janvier Development and validation of an analytical method for cleaning validation: Tips & Tricks |
| 14:00-14:30 Coffee, tea and snacks Exibition open |
13:30-14:15 Mark Thompson New Product Development; Defining and justifying the approach to sterilization |
| 14:30-15:15 Mohammad Ovais Monitoring and trending of cleaning data |
14:15-14:45 Plenary Q&A |
| 15:15-16:00 Dr. Andreas Flückiger Improving quality of Health Based Exposure Limits (HBELs). Current best practices based on guidance by EMA, PIC/S and ASTM Standard E-3219 |
14:45 – Close-out |
| 16:00-17:30 Workshops |
SPEAKERS
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Speaker Susan B. Cleary, |
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SPONSORS
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