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FDA and NAMSA Webinar: Reducing Regulatory Burden and Streamlining FDA Review Through ASCA Pilot Program Utilization

Online Event

Join NAMSA and the U.S. Food and Drug Administration (FDA) as we present this upcoming webinar on July 20, 2022, regarding the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA. During this webinar, the FDA will highlight how the ASCA Pilot Program streamlines aspects of conformity assessments for medical device submissions, as well as what manufacturers can expect when they submit ASCA test results to the government agency.

PDA Midwest Ohio Networking Event

Home Bistro Cleveland, OH

It’s time to refresh your network by seeing old friends and making new connections with other Pharma professionals at the PDA Midwest Ohio Networking Event on July 20th, at Home Bistro in Little Italy – Cleveland, OH. While networking, take advantage of the first-class service at Home Bistro, while indulging in some delicious food and signature cocktails. Pricing is free for this event; however, limited space is available. So, register now to confirm your ticket!

FDA QMSR, What do the proposed changes mean for industry?

Online Event

NAMSA and the Regulatory Affairs Professional Society (RAPS) will hold this webinar to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.

Safety First: Understanding your Everyday Equipment, Tools, and Ergonomics, a Healthmark webinar

Online Event

In healthcare, we often hear the phrase “patient focus” which is designed to make decisions with the patient’s safety in mind. But all too often we forget that within the workplace, we also need to consider the safety and well-being of our sterile processing professionals who are facing the risks and doing the real work. This presentation will focus on the dangers and risks we face on a daily basis in our departments as well as provide solutions for those dangers and risks.

August Founder’s Story – Teri Sirset and Lakshmi Dasi from DASI Simulations

Rev1 Ventures 1275 Kinnear Road, Columbus

On this edition of Founder's Story, Rev 1 Ventures will host a breakfast with DASI Simulations's team who performs advanced individualized computational predictive modeling powered by artificial intelligence and computer vision to better plan for improved patient outcomes and reduced costs associated with Structural Heart Disease.

Webinar: Chemical Characterization Best Practices – Assumptions of TTC and Exhaustive Extraction

Online Event

A dramatic shift in regulatory opinions has occurred within the last several years regarding the concepts of Extractables and Leachables (E&L) testing of medical devices, commonly known as Chemical Characterization. Much of that change was driven by the 2020 revision to ISO 10993-18. Join NAMSA for this webinar to learn more about the foundations behind Chemical Characterization and to examine best practices deriving from it.

Dayton Startup Week

Dayton Arcade 35 West Fourth Street, Dayton

Dayton’s biggest annual event for entrepreneurs and startup founders is fully back in person Sept. 13-15 at the Dayton Arcade and The Hub Powered by PNC.

Choosing a Contract Manufacturer with the Right Quality and Regulatory Credentials

Online Event

MD+DI and Qmed present "Choosing a Medical Device Contract Manufacturer with the Right Quality and Regulatory Credentials." Join Spartronics Site Leaders Casey Cramer, and Ryan Carlson, on Thursday, September 15th at 2:00 PM ET for a live webinar hosted by industry leader MD+DI. The two will discuss the importance of selecting a medical contract manufacturer with the right quality and regulatory credentials to support the manufacturing of medical devices. As Site Leaders of focused medical facilities, they’ll touch upon the various quality and regulatory credentials for electronic and electromechanical medical devices. Additionally, they’ll dive into the value of the Medical Device Single Audit Program (MDSAP) and its impact on medical device contract manufacturing.

Miami University Fall STEM Career & Internship Fair

Miami University Millett Hall 500 E Sycamore St, Oxford

Join Miami University for the 2022 Fall STEM Career & Internship Fair and connect with students looking for full-time positions, summer internships and/or co-ops, or simply seeking networking opportunities.

Webinar: Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box

Online Event

The role of biostatistics during a clinical study is often underestimated and viewed merely as a black box of providing statistical inputs at the end of a trial. However, partnering early and often with a Biostatistician on the design of your IVD clinical trial can help avoid costly mistakes, such as inadequate data collection, inefficient data pipelining and data cleaning. Join NAMSA for this webinar as we examine these critical areas, provide insight on how to prevent unnecessary delays and walk through two real-world case studies.