Cleaning Process Development & Validation
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Cleaning Process Development & Validation
October 23, 2019 @ 8:30 am - October 24, 2019 @ 3:30 pm
23rd-24th October 2019, Copenhagen
By ValidEire ApS and Key2Compliance, sponsored by Novatek International
SUMMIT DESCRIPTION
This two-day conference put focus on Science, Risk and Statistics-based Cleaning Process Development and Validation. Presentations will be given on standards, analytical methods and use of statistics to cleaning validation development, risk evaluation, Swab Recovery, data integrity, variability, what’s coming and much more.
AGENDA
| Day 1 – 23th October, 2019 | Day 2 – 24th October, 2019 |
| 08:30 Breakfast & Networking | 08:30 Breakfast & Networking |
| 08:55 Intro by Chairperson | 08:55 Intro by Chairperson |
| 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 (CPCI) | 09:00-09:45 Statistical Determination of Swab Recovery Factors in Coupon Studies – Ioanna-Maria Gerostathi |
| 09:45-10.30 Upcoming ASTM “Standard Guide for the Derivation of Health Based Exposure Limits (HBELs)” for Drugs and Devices – Andreas Flückiger | 09:45-10:30 Data Integrity in Cleaning Validation and Case Study from Novatek International Cleaning Validation Management – Laurence O’Leary (ValidEire) & Susan Cleary (Novatek) |
| 10:30 -10:45 Networking break / Coffee & Tea | 10:30-10:45 Networking break / Coffee & Tea |
| 10:45-12:00 Analytical Development: a Useful Support for Cleaning Control and Validation – S. Janvier (SERVIER) | 10:45-11:30 Statistically-based Qualification of Visual Inspection to Comply with EMA’s Q&A #8 – Andrew Walsh (CPCI) |
| 12:00-13:00 Lunch | 11:30-12:15 Different strategies to establish a rationale for samplings of different residuals – Pierre Devaux (Theraxel) |
| 13:00-13:45 Application of Statistics to Cleaning Process Development – Ruijin Song (CPCI) | 12:15-13:00 Lunch |
| 13:45-14:30 Use of Statistics for Cleaning Validation – Igor Gorsky (Valsource) | 13:00-13:45 What’s coming? New Equipment, New Technology, New Processes – Igor Gorsky (Valsource) |
| 14:30-14:45 Networking break / Coffee & Tea | 13:45-14:30 Implementation of “At-Line” PAT using Total Organic Carbon (TOC) Analysis – Andrew Walsh (CPCI) |
| 14:45-15:30 Coverage test experience and cycle development – Marilyne Douez (Novo Nordisk) | 15:15 Closing from Chairman |
| 15:30-16:15 Application of QRM in Cleaning – Ken Farrugia (Natrix Sciences) | |
| 16:15-17:00 Cleaning Process Risk Evaluation — A Quantitative Framework – Mohammad Ovais | |
| 17:00 Wrap-up | |
| 17:00-18:00 Networking and snacks compliments of sponsor Novatek |
SPEAKERS
Laurence O’Leary |
Pierre Devaux |
Ioanna-Maria Gerostathi |
Kenneth Farrugia |
Andrew Walsh |
Joe Cagnassola |
Ruijin (Sophie) Song |
Mohammad Ovais |
Susan B. Cleary |
Andreas Flückiger |
Marilyne Douez |
SPONSORS
About Novatek International
Established in 1996, Novatek’s mission is dedicated to help pharmaceutical companies and other life science organizations leverage their investment in information technology and quality processes by reducing cost, improving productivity and enhancing compliance. With over 20 years of user experience and developer level technical support, simple or complex installations are seamless and rapid. The architecture of all Novatek solutions are out of the box, modular and process-based, enabling the applications to be delivered “business-ready” providing the building blocks for a complete quality solution.
For more information on Novatek International visit: ntint.com
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