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Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat

Oct 14, 2020
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

This training course is designed to benefit organizations that are pursuing development of a parametric release moist heat sterilization program as well as organizations seeking to improve conventional moist heat sterilization programs. This lecture and discussion training course will provide an introduction and overview of parametric release, which is based on the sterilization program principles summarized in the 2012 Revision of PDA Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat.

Global parametric release requirements will be summarized along with best demonstrated practices that can be utilized to efficiently comply with these requirements. Topics will include the history of parametric release, limitations of the sterility test, sterilization science (microbiology and thermal science), essential elements of a parametric release program, recommended submission content and a workshop on the application of quality risk management.

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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 will not be provided, but 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. Describe the limitations of the Sterility Test in the disposition of sterile products
    2. List the prerequisites and requirements for parametric release
    3. Explain and implement the essential elements of a Parametric Release Program
    4. Discuss the recommended content of parametric release submission documentation for regulatory agency approval
    5. Utilize risk assessment to mitigate potential sterility risks to strengthen the moist heat sterilization program
  • Who Should Attend

    This training course is intended for professionals who contribute to or are directly responsible for the design, development, qualification and ongoing control of state-of-the-art moist heat sterilization programs.

    Departments
    Engineering, Facilities, Manufacturing, Packaging, Pharmacy, Quality Assurance, Quality Control, Quality Systems, Quality Compliance, Regulatory Affairs, Research and Development, Supply Chain, Training, Validation

    Roles
    Analyst, Auditor, Consultant, Director, Engineer, Manager, Microbiologist, Operator, Pharmacist, Scientist, Specialist, Supervisor, Technician

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By August 28, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After August 28, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* 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.

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].

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