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Parenteral Drug Association Connecting People, Science and Regulation ®

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.

Who should attend?

This course is designed specifically for people having an interest in Freeze-Drying. The audience can come from the various horizons of people performing technical risk assessment, including, but not limited to: production, quality assurance, validation, engineering and development specialist.

Learning Objectives

Upon completion of this course, you will be able to:
  • Better understand the Freeze-Drying process explained through the different examples
  • Master ICH Q9 approach in term of risk-based approach
  • Recognize a critical parameters for a process
  • Score the criticality of a parameters
  • Work in team by reaching consensus around criticality levels


Yves Mayeresse, GlaxoSmithKline Vaccines
Yves Mayeresse is director in manufacturing technology inside MSAT by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for different companies. Yves has managed activities such as parenteral production, set-up of new Freeze-Drying facilities, design of Freeze-Drying cycle and development of new stabilizers for freeze-dried products. Transfer of product towards different internal and external site. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now, Yves is focusing on different technologies used for the primary and secondary operations. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. Since 2016 he is the Leader of the PDA Interest Group Lyophilization and coordinates the group's activities in Europe.

Thursday, 21 September 2017

Theoretical Part

  • Brief review of ICH Q9
  • Description of Freeze-Drying Technology
    • The equipment
    • The process
    • The product and the primary packaging items
    • The ancillary function (SIP, CIP)
    • Aseptic level (automatic loading, people presence)
  • Tools Presentation
    • Input / Output parameters
    • Dependent / Independent parameters
    • CQA: Critical Quality Attributes
    • FMEA approach
    • Examples
Coffee Break

Practical Part

  • Team rule and organization
  • Part I: Product
    • Independent parameters linked to formulation
    • Independent parameters linked to freeze-dryer load
  • Part II: Process
    • Independent parameters linked to the freeze-dryer
Lunch Break

Practical Part

  • Part II (continued): Process
    • Independent parameters that are measured and controlled during the cycle
    • Dependent parameters linked to the Freeze-Drying cycle
  • Part III: Critical attributes linked to Freeze-Drying process
  • Part IV: Ancillary Function
    • SIP
Coffee Break

Practical Part

  • Part IV (continued): Ancillary Function
    • CIP
  • Part V: Aseptic Level


  • Q&A
  • Feedback about the approach

End of Training Course

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

Are you entiteld to receive a discount? Need Help?

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