Join AdvaMed and Emma International on August 18th for a free virtual webinar on the current regulatory landscape as they discuss how to navigate the road ahead.
The FDA recently issued a proposed rule laying out the plan for the long-awaited ISO 13485 & Quality System Regulation (QSR) Harmonization. This proposed rule comes 4 years after FDA’s first signal that they intended to overhaul 21 CFR 820 to be more closely aligned with the international standard. Join us for this free webinar as we breakdown all details of the plan, including key areas for firms to focus on within the rule, what the medical device regulatory landscape will look like after implementation, analysis on financial impact to firms, and more.
Our live webinar will be recorded. If you are unable to attend, please register and we will follow-up with a recording of the program.
Madison Wheeler, CQA
Director of Technical Operations, EMMA International
Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA) and is currently pursuing her M.S. in Quality Management.
Carmine Jabri, PhD, MSJ, MSQM, MHA
CEO, EMMA International
Carmine Jabri, PhD, MSJ, MSQM, MHA is EMMA International’s CEO. His career includes expertise in the Pharmaceuticals, Medical Device and Biologics industries. Dr. Jabri serves on the Food and Drug Law Institute’s Medical Products committee and is an internationally sought-after quality systems expert.
Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration, and a Bachelor of Science in Chemistry.
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