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PDA 544.1 Validation of Lyophilization

May 03 - May 04, 2023
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

This training course will help you gain an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes. In addition, you will gain an understanding of the basic principles of lyophilization and the techniques utilized in evaluation of lyophilized materials. During this training course, you will review and discuss different case studies and examples. Attendees are encouraged to come prepared with questions and real-life issues.

For more options and/or related training courses, please visit the page(s) below.

PDA Lyophilization Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Barbara Berglund
Barbara Berglund
CMC Turnkey® Solutions
Bio
Barbara Berglund
CMC Turnkey® Solutions

Barbara Berglund has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 20 years. Her experience includes tactical as well as strategic leadership roles in the laboratory, project management, clinical trial, and commercial manufacturing. While in project management and manufacturing, she gained direct hands-on knowledge of development stage, clinical trial, and commercial scale lyophilization of active ingredients and finished pharmaceuticals. She has managed QC groups responsible for analytical procedure transfer and validation activities in support of contract manufacturing clients and QA groups overseeing operational quality and validation teams. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007, her Green Belt certification in 2008, and ASQ certifications for CMQ/OE and CQA in 2014.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the basic design of lyophilizers
    2. Define the essential requirements for qualification of a lyophilizer and understand the impact of those tests on process design
    3. Explain the impact and limitations of analytical methods used to evaluate lyophilized materials
    4. Define the requirements for process validation for lyophilized materials
  • Who Should Attend

    This training course is intended for professionals who are involved in sterile drug lyophilization processes.

    Departments
    Engineering, Manufacturing, Quality Assurance Operations, Technical Operations, Validation

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager, Engineer, Scientist

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By March 19, 2023
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic $1,399

Regular Registration
Registration Type Price After March 19, 2023
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic $1,399

* 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.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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