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PDA 452 Application of Quality by Design and ICH Q9 Rules to Aseptic Environmental Monitoring and their Impact to Sterility Assurance

Sep 30, 2021
Washington, DC

  • Education
  • The Americas


This training course will enable participants to better use and interpret the ICH Q9 and Quality by Design (QbD) Guidelines for application in aseptic processes. Participants will learn to design and analyze their aseptic processes while considering the risk points and their management. They will also understand the impact to sterility assurance and the possibilities offered by the QbD Guidelines to improve their aseptic processes

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

PDA Quality and Compliance Training Courses


  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.


Anna Campanella
Anna Campanella
Particle Measuring Systems, Inc.
Mark Hallworth
Mark Hallworth
Particle Measuring Systems, Inc.
Ugo Ormeronye
Ugo Ormeronye
Particle Measuring Systems, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply Quality by Design (QbD) Guidelines to aseptic processes
    2. Interpret the application of ICH Q9
    3. Apply risk management for aseptic processes
    4. Design an aseptic process based on QbD
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved designing and analyzing aseptic processes for drug manufacturing.

    Quality Control, Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Technical Operations, Validation

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

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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.

Renaissance Washington, DC Hotel

999 9th Street NW
Washington, DC

  • Accommodations

    The PDA room block is not currently open. Please check back June 2021.

  • Amenities

    More information coming soon.

How to Get Here

By Air

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By Car

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Other Options

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Registration Fees

Early Registration
Registration Type Price By August 16, 2021
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699

Regular Registration
Registration Type Price After August 16, 2021
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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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