Parametric Release Call To Action

PDA Midwest Event

Parametric Release Call to Action

PDA Midwest Chapter is hosting a Global Event entitled Parametric Release – Call to Action for products terminally sterilized with moist heat. This exclusive event is being presented for the first time in the chapter’s history, which will allow for viewing/participation for the entire world!

Join us  on September 20th for a 1/2 day event on the Call to Action for Parametric Release. For those unable to attend the live streaming event, a recording of the event will be re-broadcasted later in the day with a live speaker and panelist Q&A session.

A Parametric Release (PR) program represents a significant value proposition to our industry in terms of increased safety, risk reduction and application to future modalities other than moist heat. Although PR was first approved for products terminally sterilized with moist heat by US FDA in 1985, it is not even recognized in all global regions and has not been fully embraced in regions where there are existing regulatory pathways. Our approach is to share knowledge and experiences with this best demonstrated practice to  foster collaboration across the pharmaceutical and medical device industries to address challenges and drive increased implementation of parametric release.

Here are some of the conference’s highlights:

1. Interactive discussion with speakers, panelists and participants to understand current state and future opportunities to drive the increased implementation of Parametric Release

• • Global Perspectives on Parametric Release standards and guidance

2. CONFIRMED Panelists / Speakers:

• • Rick Friedman, Deputy Director, Manufacturing Quality Office of Compliance FDA/CDER 
  • Marla Stevens-Riley, Branch Chief in Division of Microbiology Assessment  FDA/CDER 
  • Ed Tidswell, Executive Director – Merck, USP Representative
  • Mike Sadowski, Lead Scientist – Baxter Healthcare
  • Siegfried Schmitt, Vice President Technical – Parexel Consulting, UK PDA Chapter President
  • Eric Peryer, Associate Director Sterility Assurance – Baxter Healthcare
  • Frederic Ayers, Advisor – Eli Lilly and Company

3. Interactive discussion with panelists and participants to understand current state and future opportunities to drive the increased implementation of Parametric Release

• • Review of Status of Parametric Release for Products Terminally Sterilized with Moist Heat 2022 Survey* on challenges to the implementation of Parametric Release
  • Discussion of opportunities to address challenges to the implementation of Parametric Release
  • Live polling to gain further insight and drive further discussion aimed at the interests of the participants
  • Develop action items to reduce the industry over reliance on the test for sterility by increasing the implementation of Parametric Release

4. Explore opportunities for the application of Parametric Release to sterilization modalities beyond moist heat

*The Kilmer PAT/Parametric Release Collaboration Team has launched this survey to better understand the current state, challenges and opportunities to address these challenges for the implementation of Parametric Release.

Participate in this Survey 

Agenda

Current Presentations

Venue

In-Person

Hilton Chicago-Northbrook

Registration & Tickets

Thank you sponsors