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Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

Jul 23, 2020
Raleigh, NC

  • Education
  • The Americas
Cancelled

Overview

This training course is based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe. This training course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.

Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. Important moist heat sterilization topics also covered by this training course include:

  • Application of key terms including D-value, z-value, physical (F0), biological lethality (FBIO), steam quality and equilibration time
  • Considerations in the use of steam and water requirements for moist heat processes
  • Fundamentals in the selection and use of biological indicators and chemical indicators
  • Selection of a sterilization process type based on product attributes
  • Design considerations for key and critical parameters
  • Determination of cold spots
  • Practical application of semi-log survivor curve equation in sterilization calculations
  • Use the overkill approach and alternates to the overkill approach (product specific approach)
  • Use of master site and master solution approach
  • Use of bracketing approaches to optimize process qualification activities
  • Sterilizer suitability and equivalency
  • Parametric release of moist heat sterilized products
  • Impact assessment for product, process and sterilization equipment modifications

Participants will also receive a free copy of PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.

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

PDA Sterilization Training Courses

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Agenda

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

Trainers

Mike J. Sadowski
Mike J. Sadowski
Baxter Healthcare
Bio
Mike J. Sadowski
Baxter Healthcare

Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation in Round Lake, Illinois. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of sterile products across the globe. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization methods including moist heat, ethylene oxide, radiation, and aseptic processing. In addition to participation on the Task Force to revise PDA TR No.1 on Moist Heat Sterilization, he was the Chairman of the Task Force for the revision of the PDA TR No. 30 on Parametric Release. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Director and Science Advisory Board Member and is currently a member of the Education Advisory Board. Within these roles, he has successfully brought industry and regulatory agencies together to shape best practice and guidance. Mike continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. Mike received his BS in Microbiology from Purdue University in West Lafayette, Indiana.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
    2. Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
    3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
    4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types
    5. List the critical elements of process performance qualification
  • Who Should Attend

    This training course is intended for professionals who are involved in the development and assessment of sterilization processes used in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering, Process Development, Validation

    Roles
    Specialist, Supervisor, Manager, Engineer

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Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

How to Get Here

By Air

The closest airport to the training course location is the Raleigh-Durham International Airport (RDU).

By Car

Parking is available at prevailing rates in parking lots and decks surrounding the Raleigh Convention Center. Parking in the Loading Dock or inside the center (except for loading or unloading) is strictly prohibited and violators will be towed at owner’s expense. Please click here for parking maps and additional details.

Other Options

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Registration Fees

Regular Price
Registration Type Price
Member $999
Non-member $999
Gov't/Health Auth./Academic* $999



* 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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