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PDA 374.1 Technical Report No. 22: Process Simulation for Aseptically Filled Products

Dec 14 - Dec 15, 2023
9:00 AM
12:00 PM
| Eastern Standard Time
  • Education
  • Virtual
  • Online


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 live elearning 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 EU Annex 1. 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


  • Day 1
  • Day 2
  • Part 1 (15 min)

    • Welcome and Introduction
    • Objectives
    • Questions
    • Overview

    Part 2 (90 min)

    • Assurance of Sterility Through Critical Thinking
    • Process Validation

    Break (15 min)

    Part 3 (60 min)

    • Designing the Aseptic Process Simulation
  • Part 4 (75 min)

    • Reaching Conclusions
    • Investigations
    • Remediation

    Break (15 min)

    Part 5 (90 min)

    • Practical Examples
    • Failure Analysis
    • Questions Re-Visited


James  Wamsley
James Wamsley
ValSource, Inc.

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. Discuss the necessary documentation associated with process simulations
  6. 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 training course is intended for professionals who are involved in aseptic process simulations.

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

  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Director
  • Engineer
  • Scientist
  • Auditor/Inspector

Registration Fees

Register Now
Registration Type Price
All Participants $599

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