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:
- Describe the limitations of the Sterility Test in the disposition of sterile products
- List the prerequisites and requirements for parametric release
- Explain and implement the essential elements of a Parametric Release Program
- Discuss the recommended content of parametric release submission documentation for regulatory agency approval
- Utilize risk assessment to mitigate potential sterility risks to strengthen the moist heat sterilization program
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Standard Member Price$599
Health AuthorityMember Only
Mike J Sadowski
Lead Scientist, BaxterRead Bio
Mike J Sadowski
BaxterMichael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of glboal pharmaceutical and medical device products. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to participation on the Task Force for the revision of PDA TR No. 1 on Moist Heat Sterilization, he was the Chair 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 Directors and member of the PDA Scientific Advisory Board and currently serves an Associate Editor for the PDA Journal and Co-Chair of AAMI WG 03 on Moist Heat Sterilization. He has successfully aligned industry and regulatory agencies to shape best practice and continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory Sterility Assurance professionals. Mike received his BS Degree in Microbiology from Purdue University.
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