PDA 374 Technical Report No. 22: Process Simulation 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.
Upon completion of this training course, the attendee will be able to:
- 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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$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.
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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 registration@pda.org.
Featured Trainers
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Hal Baseman, MBA
ValSource Inc.
Read Bio
Hal Baseman, MBA
ValSource Inc.
Hal Baseman is the Chief Operating Officer and a principal at ValSource Inc. Mr. Baseman has over 40 years of experience in the pharmaceutical, medical device, and biotechnology industry. He has been the Chair of the PDA Board of Directors, the Co-chair of the Science Advisory Board and Co-leader of the Process Validation Interest Group, Co-chair of the EMA Annex 1 comment repose team, Co-leader of the task force on revision of Technical Report No. 22 – Aseptic Process Simulations, Co-leader of the task force for Technical Report No. 44 – Risk Management of Aseptic Processes, Co-leader of the task force for Technical Report No. 60 on Process Validation , Co-chair of the Committee for response to the FDA and the EMA Process Validation Guidance, and the Co-chair of the expert task force for the revision to Aseptic Processing Points to Consider Parts 1 an 2. He is the Co-lead for the Kilmer regulatory collaboration team and contributor on matters related to aseptic processing.
Mr. Baseman holds an MBA from LaSalle University and B.S. Biology from Ursinus College.
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Westin Washington, DC Downtown
999 9th Street, NWWashington, DC 20001, United States
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.
Additional Hotel Information
- Rate: $331 plus applicable taxes and fees (currently 15.95%)
- Cut-Off Date: Friday, 09 August 2024