Join McDermott Will & Emery LLP and Promega tomorrow, August 28th, for our webinar: Mastering Quality Management Systems: Ensuring Compliance with the New FDA LDT Rule. In this webinar, you’ll learn the role of a quality management system in compliance with the FDA LDT rule, how the FDA will approach assay modification, and the keys to leveraging a manufacturer’s quality management system. Visit the link to register and learn more: https://bit.ly/3yWyvlu
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You’re invited to join McDermott Will & Emery LLP and Promega for our upcoming webinar: Mastering Quality Management Systems: Ensuring Compliance with the New FDA LDT Rule. In this webinar, you’ll learn: -The role of a quality management system in compliance with the FDA LDT rule - How the FDA will approach assay modification - Keys to leverage a manufacturer’s quality management system Visit the link to register and learn more: https://bit.ly/3YLgGk2
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Check out our upcoming webinar with our experts Aman Khera EMBA FRAPS FTOPRA discussing how to navigate the complexity of today's regulatory environment through continuous engagement
Unlock the key to regulatory success by learning about the hidden benefits of proactive collaboration with regulatory agencies in our webinar on April 22, 2024. Featuring Aman Khera EMBA FRAPS FTOPRA and Linda Bowen, MSc, RAC, FRAPS, this webinar will provide actionable insights and lessons learned to drive regulatory and commercial success. Secure your spot today: https://ow.ly/TZcB50QYRya
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In the premiere episode of the Ask the Expert video series, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier. https://ow.ly/HsNO50Srfky
Quality Considerations in Changing Excipient Providers
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The FDA's new ruling on Laboratory Developed Test (LDT) manufacturers, effective July 2024, is bringing significant shifts to regulatory compliance. I am excited to share my team's deck that provides actionable insights to help your organization navigate these updates effectively and prepare for the FDA’s five stage phaseout policy. Access the key takeaways and strategic guidance below and learn more here: https://bit.ly/4dLpfPy
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Calyx’s #Regulatory Consultants provide insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in 2024. Read the blog. https://lnkd.in/gUvs5-qY #RIM #RegulatoryInformationManagement #ChooseCalyx
The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants | Calyx
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Calyx’s #Regulatory Consultants provide insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in 2024. Read the blog. https://lnkd.in/gxk65vMf #RIM #RegulatoryInformationManagement #ChooseCalyx
The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants | Calyx
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Calyx’s #Regulatory Consultants provide insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in 2024. Read the blog. https://lnkd.in/gMRYheFT #RIM #RegulatoryInformationManagement #ChooseCalyx
The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants | Calyx
calyx.dsmn8.com
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Calyx’s #Regulatory Consultants provide insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in 2024. Read the blog. https://lnkd.in/eD_MFrF9 #RIM #RegulatoryInformationManagement #ChooseCalyx
The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants | Calyx
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Calyx’s #Regulatory Consultants provide insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in 2024. Read the blog. https://lnkd.in/gdfF4e5W #RIM #RegulatoryInformationManagement #ChooseCalyx
The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants | Calyx
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