"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
Scandic Kødbyen, Copenhagen, Denmark October 23-24, 2019
This two-day, intensive summit brings together the industry leaders on science and 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. Attendees will therefore gain a deeper understanding of the new ASTM E3106 Standard, 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 and workshops, the conference will also provide many opportunities for networking. Read more about the individual presentations in the full agenda.
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.
Day 1, October 23rd
- Introduction to ASTM E3106 "Standard Guide for Science-Based
and Risk-Based Cleaning Process Development and Validation" and upcoming Standards
Andrew Walsh (CPCI)
- Upcoming ASTM "Standard Guide for the Derivation of Health Based Exposure Limits (HBELs)" for Drugs and Devices
- Analytical Development: a Useful Support for Cleaning Control and Validation
S. Janvier (SERVIER)
- Application of Statistics to Cleaning Process Development
Ruijin Song (CPCI)
- Use of Statistics for Cleaning Validation
Igor Gorsky (Valsource)
- Coverage test experience and cycle development
M. Douez (Novo Nordisk)
- Application of Quality Risk Management in Cleaning
- Cleaning Process Risk Evaluation — A Quantitative Framework
Mohammad Ovai (Singapore)
Day 2, October 24th
- Statistical Determination of Swab Recovery Factors in Coupon Studies
- Data Integrity in Cleaning Validation and Case Study from Novatek International Cleaning Validation Management
Laurence O’Leary (ValidEire) & Susan Cleary (Novatek)
- Statistically-based Qualification of Visual Inspection to Comply with EMA's Q&A #8
Andrew Walsh (CPCI)
- Different strategies to establish a rationale for samplings of different residuals
Pierre Devaux (Theraxel)
- What's coming? New Equipment, New Technology, New Processes
- Implementation of "At-Line" PAT using Total Organic Carbon (TOC) Analysis
Andrew Walsh (CPCI)
- Understanding and Controlling Variability with the Cleaning Process
Joe Cagnassola (Alcon, Novartis)
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):
14 750 DKK (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:
2-3 persons 10%
4 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.
1 week prior the conference you will receive login details to www.Gate2GMP.com where you can download the conference handouts as a PDF.
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.