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2023 PDA_Training-1988x680

PDA EU00182 Practical Guidance on Formulation Development for Lyophilised Pharmaceuticals

Sep 14, 2023
Seville, Spain

  • Education
  • Europe

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Overview

A successfully optimized freeze-drying cycle will provide reliable, safe processing in an efficient manner. Each stage of the process – freezing, primary drying, and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type and amount of product per batch or container, and the capabilities of the processing equipment to be used.

This training course provides an overview of how to develop an optimized freeze-drying process. It will go through each critical stage required to optimize a cycle including an overview of the freeze-drying process, formulation design of freeze-dried products, characterization of the formulation in the frozen state prior to freeze-drying, and cycle development, including the iterative approach, and the use of PAT (Process Analytical Technology) for monitoring the process.

Agenda

  • Thursday, 14 September 2023

    9:00
    Welcome, Opening Remarks and Introductions

    9.15
    Introduction to Freeze-Drying

    10.00
    Factors Effecting the Rate of Sublimation

    10.30
    Coffee Break

    11.00
    Typical CQAs and Excipients in Freeze Dried Products

    11.30
    Frozen State Characterization

    12.30
    Lunch Break

    13.30
    Overview of Process Analytical Technology Used in Monitoring Primary Drying

    14.30
    Cycle Development and Scale Up: Use of the Iterative Approach

    15.00
    Coffee Break

    15.30
    Cycle Development and Scale up: Use of the Iterative Approach

    16.30
    Round-up Discussion and Questions

    17:00
    End of Training Course

Trainers

Andrew Bright
Andrew Bright
CPI

Additional Information

  • Learning Objectives

    Learning Objectives

    • Gain a basic understanding of the freeze-drying process, together with the factors that influence the product and process.
    • Understand how to determine a product's critical temperature prior to freeze-drying.
    • Review formulation development to gain an understanding of typical excipients and their purpose in a formulation.
    • Learn about typical CQAs in freeze-dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.
    • Learn how to develop a freeze-drying process using the traditional iterative (stepwise) approach.
    • Gain a basic understanding of typical Process Analytical Technology (PAT) to monitor the freeze-drying process and to determine whether primary drying is complete.
  • Who Should Attend
    • R&D Scientists
    • Formulation Scientists
    • Product & Process Scientists/ Managers
    • Quality Control Departments

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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.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville
    Spain

    Tel: +34 954 57 94 00

    PDA Europe has reserved a limited number of rooms by 01 August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here

By Air

The hotel is only 8 kilometers away from Seville International Airport.

By Car

On site parking is available. Please contact the hotel for more information.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.055

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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