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Medical Plastics Division Virtual Technical Forum and Monthly Networking – April
April 6, 2022 @ 6:00 pm - 7:00 pm
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—–Original Appointment—–
From: Pierre Moulinie
Sent: Tuesday, February 15, 2022 4:28 PM
To: Pierre Moulinie; Gregorio.Velez@stryker.com; Vijay.Kudchadkar@Westfall-Technik.com; ned.e.lemaster@dupont.com; mreitman@exponent.com; Kumin.Yang@bsci.com; VDave1@its.jnj.com; lczuba@czubaenterprises.com; suneel.bandi@evonik.com; Don.DeMello@celanese.com; glennbeallplas@msn.com; ashter2000@gmail.com; ajay.padsalgikar@dsm.com; amin.sedighiamiri@astrazeneca.com; anil.mahapatro@wichita.edu; bmwright@teel.com; jenniferhoffman@eurofinseag.com; jmchoff@gmail.com; kulwicki_kyle@network.lilly.com; kyle.kulwicki@kimballelectronics.com; m_hanna@yahoo.com; makoto.yamaguchi@ewikonusa.com; mwallick@invibio.com; natedoyle@gmail.com; nathan.rader-edkin@bd.com; rayyar@lilly.com; rklein@atricure.com; satyamkumar.modi@terumobct.com; selvaanish.selvam@clariant.com; shah@tepha.com; wjaekel@teel.com; sanjayodak@msn.com; cmartin@leistritz-extrusion.com; mbulsari5@gmail.com; reeves_kristine_anne@lilly.com; KuteS@battelle.org; steele@battelle.org; lafreniere@battelle.org; Wayne@rjrsafety.com; boydde@battelle.org; Martin.Gibler@stress.com; jeremy.hemingway@stress.com; mmarcus@ewi.org; drobinson@ewi.org; aghosh@fostercomp.com; erikfoltz@gmail.com; prsdraut@gmail.com; stephanie.steichen@dupont.com; akiezulas@coatings2go.com; Rob.Haley@celanese.com; vsastri@winovia.com; Daniel.Gorsky@stress.com; rtatu@psnlabs.com; joanne@zetascientific.com; Tony.Walder@lubrizol.com; Jennifer.Green@Lubrizol.com; smata@LHBlind.org; JEllis@ewi.org; c.moran@compoundingsolutions.net
Cc: Diana Peninger; John Smothers; Raeginia Shepherd
Subject: Medical Plastics Division Virtual Technical Forum and Monthly Networking – March
When: Wednesday, April 6, 2022 6:00 PM-7:00 PM (UTC-05:00) Eastern Time (US & Canada).
Where: Microsoft Teams Meeting
Note the new time for this meeting (March has been cancelled… this presentation will take place at our April telco).
APRIL SCHEDULE
Speaker:
Vinny Sastri
Winovia LLC
Title and Abstract:
Focus on the Latest Regulatory and Risk Management Requirements for Medical Plastics
The last five years have brought about significant changes to global regulatory and risk management requirements for medical devices, including stringent considerations for the plastics used in these applications. The requirements stem from the European Medical Device and In-Vitro Device Regulations (EU MDR and EU IVDR), the biocompatibility standard ISO 10993:2018 and risk management for medical devices ISO 14971:2019. The General Safety and Performance Requirements in the EU MDR and EU IVDR stipulate several requisites (including risk management) when considering plastics for medical device applications. In addition, biocompatibility must be linked to the risk management process. The FDA has also published a guidance document on biocompatibility and risk management requirements. This presentation will highlight the key regulatory and risk management requirements for plastics and their additives used in medical devices all the way from design and development to processing, manufacturing and use.
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What: Medical Plastic Division – Virtual Technical Forum & Networking Event
When: 1st Wednesday of the Month; 6PM-7PM EDT
Agenda: 6:00PM-6:30PM EDT Invited Speaker / Technical Seminar (20 min seminar; 10 min Q&A)
6:30PM-7:00PM EDT Networking (topical break out rooms lead by BoD members)
This is a free event open to anyone interested in informally meeting and networking with the Medical Plastics Division.
Please email Louis Somlai <somlai_louis@lilly.com> or Pierre Moulinie <pierre.moulinie@covestro.com> to be added to the distribution or if you are interested in presenting