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2020 Freeze Drying

Critical Assessment of Lyophilized Products - Using Analytical, Visual and Mechanistic Approaches

Sep 23, 2020
Dublin, Ireland

  • Education
  • Europe
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Overview

This training course provides an overview of typical critical quality attributes (CQAs) of freeze-dried products, and why it is crucial to assess these at each stage of development to aid in the development of a suitable freeze-drying formulation and manufacturing process. It will examine several different types of analysis that can be applied to the liquid material prior to freeze drying, after reconstitution and also the freeze-dried material. By understanding the CQAs of a freeze-dried product and identifying appropriate analytical techniques, methodologies such as quality by design (QbD) can be applied in the development process. By doing so, a high level of quality control and consistency can be achieved in the final product, which can limit batch to batch variation. Other methods such as in-process analytical techniques (PAT) will also be demonstrated and provide an understanding on how to apply these to optimizing the manufacturing process for the freeze-dried product. This will be an interactive training course which will include a practical exercise in which the participants will assess products in vials and relate their observations to the freeze-dried product, formulation and freeze-drying cycle.
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Agenda

  • 9:00
    Welcome, Opening Remarks and Introductions

    9:15
    Introduction to Freeze-Drying

    9:30
    Overview of Typical Critical Quality Attributes of a Freeze-Dried Product

    10:30
    Coffee Break

    11:00
    Overview of Analytical Methods and Approaches for Freeze-Dried Products and Case Studies

    12:00
    Overview of Process Analytical Technology used in Monitoring Primary Drying

    12:30
    Lunch Break

    13:30
    Assessing Structural Properties of Freeze- Dried Products

    14:30
    Practical Exercise Assessing Typical Structural Patterns in Freeze-Dried Products

    15:00
    Coffee Break

    15:30
    MicroPress: Novel Technique in Measuring Mechanical Properties of Freeze-Dried Products

    16:30
    Round-up Discussion and Questions

    17:00
    End of Course

Additional Information

  • Learning Objectives

    Learning Objectives

    • Learn about typical CQAs in freeze dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.
    • Gain a basic understanding of typical analytical techniques that can be applied to freeze dried products.
    • Recognize the value of analytical assessment for freeze dried products to aid in the development of products and the manufacturing process using quality by design.
    • Learn to visually assess freeze dried products and understand what factors affect their appearance, structure and physical properties
  • Who Should Attend

    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.

Crowne Plaza Dublin Airport

Northwood Park
Dublin, Ireland

Crowne Plaza Dublin Airport
  • Accommodations

    Hotel Nearby
    PDA Europe recommends the reservation at one of the following hotel.
    The general terms of business are valid at the event hotels.

    Crowne Plaza Dublin Airport
    Northwood Park
    Santry Demesne
    Dublin 9

    The hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet and good bus links to the city centre.
    Each bedroom has air conditioning, an on-demand movie system, a safe and ironing facility.Crowne Plaza Dublin Northwood is set in parkland, close to the M1 and M50, and 15 minutes from Dublin city centre.

    Northwood Crowne Plaza has a coffee bar, the Cinnabar Red Bar and a Californian-Asian restaurant, for a great variety of food and drinks. Breakfast starts early at 06:00. Crowne Plaza Northwood offers a park and fly facility and is on the airport bus route. Omni Shopping Centre, Swords Pavillions, Movie Plex and Northwood Business Campus are nearby. Croke Park Stadium is a short drive away.

    PDA Europe has reserved a limited number of rooms until the 24th July 2020
    Book your room for the PDA Group Rate

    • Single Superior Room € 159 per night*
    • Double Superior Room € 189 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 Airport:

Dublin Airport - DUB
Airport Phone: +353 1 814 1111
9km , 10 min by car
Free Shuttle Bus fom and to the Hotels

By Car

The hotel is almost 10km away from the Dublin Airport.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €895



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

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.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

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 [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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