"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Aseptic filling

Aseptic Manufacturing
– Maintaining the validated state

Conference - 21-22 October 2020
Industriens hus, Copenhagen, Denmark


A collaboration between:


Conference description:

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 .

Conference objective:

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. 10 July):

Download the program/agenda and speaker bio's (PDF) - Rev. 10 July

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

 

 

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Sponsors

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.

 

Conference facts

Conference no:
5255
Industry:
Pharmaceuticals

Level:
Advanced
Region:
EU/Global

Language:
English
Speakers:
Specified in the program

Date, location and venue:

21-22 October 2020, Copenhagen, Denmark
Industriens hus
H.C. Andersens Blvd. 18    

Register by 9 Sept. - Save 1 350 DKK (€ 180)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Other Scandic Hotels nearby:
» Scandic Webers (1000m)
» Scandic Copenhagen (1200m)


Agenda:

Day 1
08.45-09.20 Registration, breakfast and networking
09.30-16.15 Conference
16.30 – 18.00 Networking, mingling and snacks

Day 2
08.45-09.20 Breakfast and networking
09.30-15.45 Conference


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

Note. 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.


Discounts:
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.


Conference handouts  
No printed handouts will be provided at the venue.
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 policy - Compliance Seminars®  

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.