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PDA 444.1 Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat

Dec 01 - Dec 02, 2021
9:00 AM
-
12:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This live eLearning 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 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.

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

PDA Sterilization Training Courses

Agenda

  • Day 1
  • Day 2
  • Welcome and Introductions (15 min)


    Definitions and History of Parametric Release; Issues/Limitation of the Sterility Test (75 min)


    Break (15 min)


    Sterilization Science: Microbiology and Engineering (60 min)


    Wrap-Up / Q&A (15 min)

  • Day 1 Recap / Q&A (15 min)


    Parametric Release Program Elements and Fundamentals (75 min)


    Break (15 min)


    Sterility Assurance Risk Management and Submission Documentation (60 min)


    Wrap-Up / Q&A (15 min)

Trainers

Michael Sadowski
Michael Sadowski
Baxter Healthcare

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
  • Quality Control
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Facilities

Roles
  • Analyst
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Director

Registration Fees

Register Now
Registration Type Price
All Participants $599

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