PDA 374 Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products
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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 training course 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 training course 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.
PDA Aseptic Processing Training Courses
PDA Regulatory Training Courses
- Identify the updated scientific and regulatory technology and expectations in the design, operation, and interpretation of process simulations
- Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment, and ongoing evaluations
- Describe how to use risk management as it applies to aseptic processing simulations
- Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
- Explain why environmental monitoring is an important element of process simulations
- 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
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Standard 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].
Day 1
Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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Request InformationPLEASE 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 Downtown Hotel
999 9th Street NWWashington, DC , USA
Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $322 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, 15 August 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.
To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.
Individual Cancellation
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.
Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Set in the heart of the city, our upscale hotel is steps from Capital One Arena, Penn Quarter and the Walter E. Washington Convention Center. From museums to entertainment, this is the perfect base for exploring downtown D.C. Fuel up for a busy day downtown with breakfast weekdays at Mixx or weekends at Fifteen Squares Restaurant. Our Grand Ballroom, meeting rooms and 11th-Floor Terrace are also available for a host of multi-sensory events, from important conferences to joyful weddings. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi and suites with beautiful terraces.