PDA Midwest Event
Parametric Release Call to Action
PDA Midwest Chapter is pleased to announce that the chapter will partner with the Hilton Chicago Northbrook Hotel in Northbrook, IL to provide for an exclusive, first time in the chapter’s existence, Global Hybrid Event, allowing viewing/participation for the entire world!
Join us in person on September 20th at the Hilton, for a 1/2 day event on the Call to Action for Parametric Release. Alternately for those who are not able to attend in person, we will be live streaming the event. For those unable to attend the live event (in-person or streaming), a recording of the event will be re-broadcasted later in the day with a live speaker and panelist Q&A session.
In person attendance includes the following:
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- 50% discount on an electronic copy of TR-30 (normal member price is $180 and non-member $325)
- Two people will have the opportunity to win a FREE copy of TR 30, which will be raffled off
- A mid-morning refreshment break and networking opportunity
- Following the meeting, lunch will be served allowing you to continue your discussions and networking
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:
- Interactive discussion with speakers, panelists and participants to understand current state and future opportunities to drive the increased implementation of Parametric Release
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- Global Perspectives on Parametric Release standards and guidance
- Invited Panelists / Speakers:
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- FDA/CDER Leader in Division of Microbiology Assessment
- FDA/CDER Field Compliance Leader, Manufacturing Quality
- 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
- Interactive discussion with panelists and participants to understand current state and future opportunities to drive the increased implementation of Parametric Release
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- 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
- Explore opportunities for the application of Parametric Release to sterilization modalities beyond moist heat
*Link will be provided when survey launches on August 9th, 2022
Agenda
Current Presentations
Venue
In-Person
Hilton Chicago-Northbrook
2855 N. Milwaukee Ave.Northbrook, IL 60062
Streaming
Link will be provided in an email after registration and prior to the event
Registration & Tickets
Thank you sponsors
