Aseptic Processing Essentials Workshop (PDA 374)
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Registration Options
Individual Registration
Group Registration
OVERVIEW
The objective of aseptic processing is to prevent the microbiological contamination of sterile product manufactured using the process. The verification of the ability of the process to produce sterile product is evaluated by aseptic process simulation studies or media fills.
This essentials workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The workshop will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre- and post incubation inspections, incubation conditions, acceptance criteria and investigations, and corrective actions. The use of risk-based decision making will be considered.
Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.
LEARNING OBJECTIVES
Upon completion of this event, the attendee will be able to:
- Identify the current scientific and regulatory expectations for aseptic process simulations in industry and in EMA Annex 1 and FDA Guidance.
- Describe how to use critical thinking and risk management as it applies to aseptic processing simulations.
- Discuss aseptic process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment, intervention evaluation and inclusion, and ongoing evaluations.
- Discuss how process simulations can be applied to various types of aseptic processes and aseptically processed products.
- Discuss the necessary documentation associated with process simulations.
- Apply modern concepts to establish appropriate acceptance criteria for aseptic process simulations, evaluate the results, and, as necessary, investigate any failures and recommend appropriate corrective and preventive actions.<
WHO SHOULD ATTEND
This event is intended for professionals who are involved in aseptic process simulations.
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Location and Travel
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.
PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814 USA
Accommodations
The following hotels are located near the event location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD
20814
How to Get Here
Registration
Pricing Options
Early Registration
Register by 17 October 2026
Member Price
$899GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,079
Standard Registration
Register after 17 October 2026
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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