Upcoming Webinars
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FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry
In this webinar, Denise Holliday, Expert Witness at Capwell Consulting Group, helps you understand how the transition to QMSR may affect regulatory compliance, product liability exposure, and organizational risk.
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Past Webinars
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From Hospital to Home: Mastering Home-use Medical Device Warnings and Labels
By exploring critical aspects of product liability and risk mitigation strategies, this presentation aims to educate companies on home-use medical device labels and warnings to protect interests while ensuring consumer safety.
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Revolutionizing Medicine: The Race to Unlock the Power of Gene Therapy and Build a Competitive Edge
Gene therapies have been the subject of tremendous research and investment in the biotechnology and pharmaceutical fields.
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The Future of Cosmetics Regulation is MoCRA - The Modernization of Cosmetics Regulation Act
For the first time since 1938, the U.S. federal cosmetics regulations have been updated with significant implications for businesses in all sectors of the cosmetics industry. MoCRA aligns the cosmetics regulations with other FDA-regulated areas, including food, drugs, and medical devices while also expanding the FDA’s enforcement powers.
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Transition From COVID-19 Emergency: Demystify the FDA Requirements to Keep Your Device on The Market
Transition From COVID-19 Emergency: Demystify the FDA Requirements to Keep Your Device on The Market This webinar will cover: • What are the main groups of medical devices impacted? • High level: How to go from EUA to traditional submission (EUA guidance doc). • High level: Phased approach to traditional submission – non-EUA (Phased guidance doc). • Legal ramifications: Overview and Prospective.
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