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2019 FD

Freeze Drying for Advanced Users - A Risk-Based Approach

Sep 26, 2019
Berlin, Germany

The objective of this course is to give an understanding of risk management through ICHQ9 applied to the freeze-drying process.

  • Education
  • Europe

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Overview

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 session will go beyond the validation process and will integrate other aspect such as: Equipment troubleshooting, management of deviation, influence of raw material and PAT tool application. 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, Aseptic Level, raw material and how to manage deviation in an effective way. 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.

Agenda

  • Thursday, 26 September 2019

    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

Trainers

Yves Mayeresse
Yves Mayeresse
GlaxoSmithKline Vaccines

Additional Information

  • Learning Objectives

    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
    • Manage deviations in an efficient way
  • Who Should Attend

    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, deviation management, including, but not limited to: production, quality assurance, validation, engineering and development specialist.

  • 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:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    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.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

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Berlin Marriott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany

Make a Reservation
Berlin Marriott Hotel
  • Accommodations

    Hotel Website

    Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

    Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

    Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

    PDA Europe has reserved a limited number of rooms until the 23rd August 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 195 per night*
    Double Room € 215 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 Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (9 km), 18 min by car
Alternate transportation: Limousinen Service; fee: 100 EUR (one way); reservation required
Estimated taxi fare: 25 EUR (one way)
Bus service, fee: 2.8 EUR (one way)
Subway service, fee: 2.8 EUR (one way)
Take the Bus X9 and get off at Zoologischer Garden, then take the subway U2 towards Pankow and get off at Potsdamer Platz.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
12.7 mi (20.4 km), 25 min by car
Alternate transportation: Limousinen Service; fee: 130 EUR (one way); reservation required
Estimated taxi fare: 45 EUR (one way)
Bus service, fee: 3.6 EUR (one way)
Subway service, fee: 3.6 EUR (one way)
Take the train S45 to S-Bahnhof Suedkreuz. Then change to the S-train S2 and get off at Potsdamer Platz.

By Car

The Berlin Marriott Hotel is located at Inge-Beisheim Platz 1.

Other Options

Berlin Central Station: 2.3 mi from hotel.

Train Station Berlin Friedrichstrasse: 1.1 mi from hotel.

Directions

Registration Fees

Early Registration
Registration Type Price
All Participants €895
Regular Registration

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

Are you entiteld to receive a discount? Need Help?

All Participants

895 Euro

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

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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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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