"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
– Maintaining the validated state
Conference - 21-22 October 2020
Industriens hus, Copenhagen, Denmark
This two-day intensive summit brings together the industry leaders in compliance, aseptic manufacturing and maintaining the validated state. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of aseptic manufacturing. Attendees will therefore gain a deeper understanding of the new messages from the new Annex 1 draft, FDA focuses on inspecting sterile facilities, sterilisation, process validation, life cycle approach and more. The conference will showcase some of the tech that impacts aseptic manufacturing.
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 aseptic manufacturing process strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated state.
The conference is primarily relevant for R&D staff, Production Leaders, Supporters, Commissioning, Qualification and Validation teams and Quality Assurance seeking the latest knowledge about risk- and cross contamination control, as well as engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experiences.
Conference outline (Rev. 25 June):
Day 1, October 21st
Moderator: Laurence O’Leary, ValidEire Aps
- Intro to Day 1 by Moderator
- EU Annex 1- Manufacture of Sterile Medicinal Products
Pierre Devaux, Theraxel/Delegate
- System Real Time Data Integrity, Electronic Sample Collection in Controlled Areas.
Susan Cleary, Novatek International
- Plenary Q&A
- Equipment Sterilisation for Aseptic Manufacturing
Josh Thompson, MTL projects
- Equipment and Facility design of an Aseptic Facility
Robert J. Hayes, SeerPharma (UK)
- Cleanroom cross-contamination control
Pierre Devaux, Theraxel/Delegate
- Plenary Q&A / Wrap up
Snack and refreshments
Complimentary of Novatek International
Day 2, October 22nd
Moderator: Pierre Devaux, Theraxel
- Intro to Day 2 by Moderator
- Media Fill studies
Gavin Ross, Founder, GTR Pharma
- Aseptic training with VR
Sebastian Scheler, CEO & Lead Psychologist, Innerspace
- Plenary Q&A
- Annex 1 & Environmental monitoring
Matt Kite, Lighthouse Worldwide Solutions
- Process Validation
Laurence O’Leary, ValidEire
- Plenary Q&A / Wrap-up
Specified in the program
Date, location and venue:
08.45-09.20 Registration, breakfast and networking
16.30 – 18.00 Networking, mingling and snacks
08.45-09.20 Breakfast and networking
Price (excl. local VAT):
Early bird to 9 September:
13 500 DKK (1 795 EUR)
After 9 September: 14 850 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:
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.