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PDA 514 Filtration Processes in the Pharmaceutical and Biopharmaceutical Industry

Aug 07 - Aug 10, 2023
Bethesda, MD

  • Education
  • The Americas
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Overview

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

Filtration processes are manifold and often critical within biopharmaceutical processes. Knowing different filter types, use, and criticalities will help to make appropriate choices of which filter should be used where, what is required to size a filter system appropriately, what to look out for and, if needed, how to troubleshoot filtration problems. Moreover, filter integrity testing is as much a key success factor of sterilizing grade filtration as the filter itself. Again, the right choice of test, when to test and what to do when a test fails are critical knowledge points within the filtration processes.

This interactive training course addresses the following topics:

  • Design, construction and manufacturing of pre-, depth, and membrane filters
  • Contaminant retention mechanisms for liquid and gas filtration including sieve retention and adsorptive sequestration
  • Pre-/Post-use integrity testing using diffusional airflow, bubble point, pressure-hold, and water intrusion test
  • Process validation requirements for membrane filters, including microorganism challenges, extractables, and other testing parameters
  • Troubleshooting integrity test and filtration process design issues
  • Filter material, size, and combination choices
For more options and/or related training courses, please visit the page(s) below.

PDA Filtration 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

Faith Gilmore
Faith Gilmore
MilliporeSigma
Bio
Faith Gilmore
MilliporeSigma

Faith Gilmore is a Senior MSAT Engineer & Technical Consultant at MilliporeSigma, specializing in sterile filtration and integrity testing. She started her career with MilliporeSigma as a product development engineer developing pleated sterilizing-grade and prefilter devices. She later moved into a Quality role within single-use assembly manufacturing working on key quality initiatives, including a technology transfer to a new production facility in China. Today, she works in the commercial organization, supporting customers in the areas of sterile filtration and integrity testing through consulting, training, process reviews, and projects. Faith holds Bachelor's and Master's degrees in Biomedical Engineering from Worcester Polytechnic Institute.
Annie Leahy
Annie Leahy
MilliporeSigma
Bio
Annie Leahy
MilliporeSigma

Annie Leahy is an MSAT Manager in the North American Manufacturing Sciences and Technology (MSAT) group within MilliporeSigma. She leads a highly technical team that ensures successful implementation and ongoing operation of customer applications across the manufacturing process. Her area of expertise focuses on virus and aseptic filtration operations as well as supporting customers during their manufacturing process to provide best practices and ensure optimal processing conditions. Annie has over 14 years of experience, which has included developing improved methods for virus spike preparations and mycoplasma retention methods as well as conducting virus and aseptic filtration applications studies at both small and large scale. She holds a BS in Biology from Dickinson College and an MS in Biotechnology from Northeastern University.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply knowledge of filter properties to select the appropriate filter for a specific process
    2. Design and select different integrity test methods
    3. Differentiate and optimize pre-filter and final filter arrangements
    4. Identify filterability and scalability requirements for filtration optimization
    5. Describe validation and process performance qualification requirements
    6. Resolve integrity test failures and troubleshoot filtration process issues
  • Who Should Attend

    This training course is intended for professionals who design, develop, validate and perform filtration processes.

    Departments
    Manufacturing, Quality Assurance Operations, Quality Control, Process Development, Engineering, Validation

    Roles
    Supervisor, Manager, Specialist, Operator/Technician, Scientist, Process Engineer, Reliability Engineer

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Travel

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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.

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Registration Fees

Early Registration
Registration Type Price By June 23, 2023
Member $4,049
Non-member $4,859
Gov't/Health Auth./Academic $3,149


Regular Registration
Registration Type Price After June 23, 2023
Member $4,499
Non-member $5,399
Gov't/Health Auth./Academic $3,149


* 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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