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2019 BioManu

Interest Group Meeting Freeze Drying

Sep 02, 2019
Munich, Germany

Ensuring Quality in the Freeze Drying Process and Discussion of the Benefi ts of a Novel Freeze Drying PDA Technical Report

  • Interest Group
  • Europe
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Overview

PDA is proud to announce the Interest Group Meeting Freeze Drying as a kick-off to the inaugural 2019 PDA Europe BioManufacturing conference!

Join us in the beautiful city of Munich and take advantage of the open forum design approach offered by this focused Interest Group meeting. Hear presentations from leading experts and interact and discuss your experiences with colleagues in an open atmosphere. Share your opinion and expand your knowledge in interactive discussions. Receive the latest information about the status of the ongoing activities of the Interest Group Freeze Drying.

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Agenda

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  • Monday, 02 September 2019

    10:00
    Welcome Coffee

    11:00
    Kerstin Wilken, PDA Europe
    Yves Mayeresse, GSK Vaccines
    Anthony Cannon, MSD

    Quality for Freeze Drying
    Moderator: Yves Mayeresse, GSK Vaccines
    • Media Fills
    • Leak rate testing and the link to sterility
    • How to read data within the freeze-drying cycle
    • How to manage deviation – practical advice

    Qualification and Process Validation
    Moderator: Maik Guttzeig, Bayer
    • Comparability of different Freeze Dryers – how to optimize the number of qualification batches
    • Challenges encountered with the use of Surrogates and Placebos
    • New Technologies

    13:00 – 14:00
    Lunch Break

    14:00
    PDA Technical Report Freeze Drying
    Moderator: Yves Mayeresse, GSK Vaccines
    • What are the benefits of a newly compiled Technical Report for our industry?
    • Current Challenges and Hot Topics: what should the Technical Report cover?
    • How to volunteer for being part of a technical report?

    15:30 – 16:00
    Coffee Break

    16:00
    Summary and Group Discussion

    17:00
    Conclusion and Farewell

    Yves Mayeresse, GSK Vaccines
    Anthony Cannon, MSD
    Kerstin Wilken, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    • How to assess equipment equivalence
    • How to assess process equivalence for validation
    • What is the minimum load to be validated in a freeze-dryer
    • What the link between leak rate and sterility of the freeze-dryer
    • How to implement and use PAT tools such as NIR, Pirani/MKS
  • Why Attend

    Why Attend

    As a kick-off to this year’s inaugural PDA BioManufacturing conference, the Interest Group Freeze Drying will meet in Munich/Germany on Monday, 2 September 2019 to present following ideas:

    Presentations around:

    • Technical Evolution in Term of Cooling Equipment for Freeze-Dryer
    • State of the art validation approach for freeze-dried products

    You do not need to be a PDA member to register for this meeting. Everybody is welcome!

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sheraton Munich Arabellapark Hotel

Arabellastrasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 15th June 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 169 per night* 
    Double Room € 194 per night*

    *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)
    • VAT, Taxes and Service will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone: +49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

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Registration Fees

Regular Price
Registration Type Price
All Participants €350

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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