Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes (PDA 542)
Held in conjunction with the PDA Pharmaceutical Microbiology Conference 2025
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Registration Options
Individual Registration
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Attend the PDA Pharmaceutical Microbiology Conference 2025 before the Training Course to connect with experts and set the stage for deeper learning.
A strong microbial monitoring plan and a leveraging/introduction of new technologies should be used for all sterile medicinal products and sterile active substances. As required by the principles of Quality Risk Management, this ensures that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product.
This training course provides tools, rationales and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging/introducing new technologies for effective sterility assurance in aseptic processes.
Specific topics include:
- FDA and EU GMPs requirements for total particle and microbial environmental monitoring for aseptic processes
- Design of an environmental monitoring plan based on risk assessment and process analysis
- New technologies and instruments for environmental monitoring: feature, scientific description and benefits
- New technologies and instruments for environmental monitoring implementation: FDA and EU GMP requirements and implementation/validation steps
Upon completion of this event, participants will be able to:
- Design a microbial monitoring plan for an effective sterility assurance in aseptic processes
- Explain the implementation of new technologies for an effective sterility assurance in aseptic processes
Please visit the PDA Environmental Monitoring Training Courses page for more options and/or related events
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Venue Details and Accommodations
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.
Grand Hyatt Washington
1000 H Street, NWWashington, DC 20001 USA
Reservation Instructions
Stay in the center of downtown Washington, DC, at the Grand Hyatt Washington, the official headquarter hotel for the PDA Training and Research Institute (TRI) Essentials Workshops and Training Courses. Discover a luxury hotel just a few blocks from the Capital One Arena, National Mall, Smithsonian Museums, and Washington Monument.
Cancellation Policy: Any reservation canceled within seventy-two (72) hours of the arrival date will forfeit one (1) night's room deposit.
How to Get Here
Area Attractions
- National Museum of Women in the Arts (approx. 0.2 mile/0.3 km)
- Ford's Theatre (approx. 0.2 mile/0.3 km)
- National Portrait Gallery (approx. 0.3 mile/0.5 km)
- Planet Word (approx. 0.3 mile/0.5 km)
- National Building Museum (approx. 0.5 mile/0.8 km)
Registration
Pricing Options
Early Registration
Register by 05 August 2025
Member Price
$899GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,079
Standard Registration
Register after 05 August 2025
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
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].
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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