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Parenteral Drug Association Connecting People, Science and Regulation ®

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

Nov 29 - Nov 29, 2018 |
Nov 29, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • 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

Instructor

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, 29 November 2018

9:00
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

10:30
Coffee Break

11:00
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

12:30
Lunch Break

14:00
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

15:30
Coffee Break

15:45
Practical Part

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

16:30
Conclusions

  • Q&A
  • Feedback about the approach

17:00
End of Training Course

3 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 (21%)

Contact

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

Exterior

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 26th September 2018

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

Photos

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
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4492

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