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PDA 374 Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products

Sep 30, 2021
Washington, DC

  • Education
  • The Americas

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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 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.

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

PDA Aseptic Processing Training Courses

Agenda

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

Trainers

Hal Baseman
Hal Baseman
ValSource Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify the updated scientific and regulatory technology and expectations in the design, operation, and interpretation of process simulations
    2. Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment, and ongoing evaluations
    3. Describe how to use risk management as it applies to aseptic processing simulations
    4. Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
    5. Explain why environmental monitoring is an important element of process simulations
    6. Discuss the necessary documentation associated with process simulations
    7. 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

    Who Should Attend

    This training course is intended for professionals who are involved in process simulation testing.

    Departments
    Quality Control (Microbiology), Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Technical Operations, Training, Validation

    Roles
    Specialist, Operator/Technician, Supervisor, Manager, Director, Engineer, Scientist, Auditor/Inspector

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Travel

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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

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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.

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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 [email protected].

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