"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Science, Risk and Statistics-based
Cleaning Process Development and Validation
Conference - 6-7 October 2020
This two-day, intensive summit brings together the industry leaders on Science, Risk- and Statistics-based Cleaning Validation. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of cleaning validation. Thus, attendees will gain a deeper understanding of the new ASTM E3106 Standard, PDA TR 29 revision, Annex 1 (new draft) and the use of statistics in cleaning validation, as well as risk evaluation and data integrity in cleaning validation among other things.
In addition to the many presentations, plenary Q&As and workshops, the conference will also provide many opportunities for networking.
The objective of this conference is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be put to use in their own cleaning validation strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to cleaning validation.
The conference is primarily relevant for R&D staff, Leaders, Supporters, Validation teams in production and Quality Assurance seeking the latest knowledge about risk- and statistics-based cleaning validation, as well as for engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experiences.
Conference outline (Rev. March-30)
Day 1, October 6st
Moderator: Laurence O’Leary, ValidEire Aps
- Introduction to ASTM E3106 "Standard Guide for Science-Based
and Risk-Based Cleaning Process Development and Validation" and upcoming Standards
Andrew Walsh (CPCI)
- Annex 1 Revision
Pierre Devaux (Theraxel)
- ASTM "Standard Guide for the Derivation of Health Based Exposure Limits (HBELs)" for Drugs and Devices
- Application of Quality Risk Management in Cleaning
Ken Farrugia (Natrix Sciences Ltd.)
- Analytical Development: a Useful Support for Cleaning Control and Validation
S. Janvier (Pierre Fabre Group )
- Application of Statistics to Cleaning Process Development
Ruijin Song (CPCI)
- Use of Statistics for Cleaning
Igor Gorsky (Valsource)
- Workshop - Plenary Q&A
- Workshop - QRM on Cleaning Validation
- Workshop - Visual Inspection Qualification
- Workshop - How to read a HBEL Monograph
How to read a HBEL Monograph
Day 2, October 7th
Moderator: Pierre Devaux, Theraxel
- Statistical Determination of Swab Recovery Factors in Coupon Studies
- Coverage test experience and cycle development
M. Douez (Novo Nordisk)
- Data Integrity in Cleaning Validation and Case Study from Novatek International Cleaning Validation Management
Susan Cleary (Novatek)
- Cleaning Process Risk Evaluation — A Quantitative Framework
- Lean Six Sigma Case Study Using Total Organic Carbon Analysis
Andrew Walsh (CPCI)
- Understanding and Controlling Variability with the Cleaning Process
Joe Cagnassola (Alcon)
- Workshop - Plenary Q&A
- Workshop - Application of Statistics to Cleaning Processes
- Workshop - Recovery method with Swabs
Specified in the program
08.30-08.55 Registration, breakfast and networking
17.00 – Networking mingle with snacks
08.30-08.55 Breakfast and networking
Price (excl. local VAT):
Early bird to August 25th: 1 795 EUR
From August 26th: 1 975 EUR
Incl. lunches and refreshments
Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the conference fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the fee.
For groups registered and invoiced together for the conference we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the conference - it is possible to make notes in the PDF files you will have access to.
3-5 days prior the conference you will receive download instructions för the conference handouts as PDF files.
Note pads and pens will be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before the conference are subjected to a service charge of 150 € (Euro)/registered day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the conference, or failure to cancel or "no-show", will be charged in full.
Cancellation of conference: The conference may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior to the start), or due to other reasons beyond our control. In such circumstances charged conference fees will be refunded, credited, or granted to attend another event for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled conference. If you need to book flights way ahead (+35 days prior the conference) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.