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

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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 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.

Upon completion of this training course, the attendee will be able to:

  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

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