Do Science, Statistics, Risk based approach sound like 21st century approaches to cleaning? Who can inform you and provide expert advice?
This year on 28th-29th April multiple Cleaning process expert speakers will attend Copenhagen and be part of Science, Risk and Statistics-based Cleaning Process Development and Validation conference. This team will present, answer panel Q&As as well as host workshops. Moderated by no other than Lars-Eric Ellow from Key2Compliance®
| 08:50-09:00 | INTRO BY MODERATOR |
| 09:00-09:45 | |
| Introduction to ASTM E3106 “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation” and Upcoming Standards – Andrew Walsh | |
| 09:45-10:30 | |
| Annex 1 Revision –Pierre Devaux | |
| BREAK 3O MINUTES | |
| 11:00-11:45 | |
| ASTM “Standard Guide e3219 for the Derivation of Health Based Exposure Limits (HBELs)” for Drugs and Devices – Andreas Flückiger | |
| 11:45-12:30 | |
| Sustainable Quality Assurance through the Application of QRM in Cleaning – Ken Farrugia | |
| LUNCH 1 HOUR | |
| 13:30-14:15 | |
| Analytical Development: A Useful Support for Cleaning Control and Validation – S. Janvier | |
| 14:15-15:00 | |
| Application of Statistics to Cleaning Process Development Andrew Walsh |
| 08:50-09:00 | INTRO BY MODERATOR |
| 09:00-09:45 | |
| Use of Statistics for Cleaning – Igor Gorsky | |
| 09:45-10:30 | |
| Statistical Determination of Swab Recovery Factors in Coupon Studies – Ioanna-Maria Gerostathi | |
| BREAK 30 MINUTES | |
| 11:00-11:45 | |
| Implement a Risk-Based, Data Integrity Compliant Cleaning Validation Management System- Susan Cleary | |
| 11:45-12:30 | |
| Cleaning Process Risk Evaluation — A Quantitative Framework – Mohammad Ovais | |
| LUNCH 1 HOUR | |
| 13:30-14:15 | |
| Lean Six Sigma Case Study Using Total Organic Carbon Analysis – Andrew Walsh | |
| Risk and Statistics-based Cleaning Process Development and Validation on 28th-29th April 2022 in Copenhagen, Denmark. | |
| Note this is a HYBRID event where you can meet speakers f2f and virtual. |
Workshops
- QRM on Cleaning Validation
- Visual Inspection Qualification
- Review of HBEL’s
- Application of Statistics to Cleaning Processes
- Recovery method with Swabs
Plenary Q&A
There will be opportunities on both days to engage with the speakers in Plenary Q&A.
Testimonials
ARRANGERS
SPONSOR
