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Application of a Risk-based Approach to Freeze-Drying Processes

Sep 21 - Sep 21, 2017 |
Sep 21, 2017 |
Lindner Hotel City Plaza | Cologne, Germany
  • Education
  • Europe
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One master piece of current process validation approach is risk analysis. It allows defining and measuring the critical parameters of the process for which a specific level of scrutiny is necessary in order to end-up with a robust process under control. The objective of this course is to give an understanding of risk management through ICHQ9 applied to the freeze-drying process. The first part will review the guidelines, the Freeze-Drying process and the tools available to score the risks. The second part will be fully interactive.

Participants will express their views in terms of detectability, occurrence and control of the various risks linked to the Freeze-Drying process. The session will be subdivided into different chapters: Product, Process, Critical Quality Attributes, Ancillary Function of the equipment and Aseptic Level. The different tools to perform risk analysis will be described and the main focus will be on an FMEA (Failure Mode and Effects Analysis) approach. The output of the workshop is a table consisting of the different parameters with their associated level of criticality that will be shared with the participant.


Elke von LaufenburgElke von Laufenberg
Manager Training & Education
Tel: +49 (0) 30 43 655 08-21
Fax: +49 (0) 30 43 655 08-66

4 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

845 Euro

All fees given in Euro and excluding VAT (7%)


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66


Lindner Hotel City Plaza
Magnusstrasse 20
50672 Cologne
Tel: +49 221 2034-700
Fax: + 49 221 2034-777
Hotel Website

Located at the trendy Friesenplatz, Lindner Hotel City Plaza welcomes its guests in style with modern, sophisticated and charming elegance. You are right in the middle of the media metropolis of Cologne and can experience everything it has to offer with a welcoming touch of luxury

The elegant rooms each have a satellite TV, a seating area, and an en-suite bathroom with complimentary toiletries. WiFi is free throughout.

PDA Europe has reserved a limited number of rooms until the 3rdJuly 2017

Book your room for the PDA Group Rate by phone.
Single Room € 129 per night*
Double Room € 159 per night*

*Rates include the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • Taxes and Service will apply

How to Get There

  • Subway (0.1 km) Station: Friesenplatz – Lines: 3,4,5,12,15
  • City train (1.0 km) Station: Hansaring – Lines: S 6, S 11, S 12
  • Tram (0.1 km) Station: Friesenplatz – Lines: 3,4,5,12,15
  • Bus (0.6 km) Station: Rudolfplatz – Lines: 136, 146
  • Metro station 120 m away


€ 25 per day


Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66

Register Now