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FDAnews Announces On-Site Inspections: They re Back — But When, Where and How Webinar August 12, 2021

FDAnews Announces On-Site Inspections: They’re Back But When, Where and How Webinar August 12, 2021 Share Article How will the clinical trial industry merge on-site audit and virtual inspection best practices? Find out how by registering today. WCG FDAnews On-Site Inspections: An FDAnews Webinar The development and distribution of COVID-19 vaccines have helped the global health crisis take a positive turn in some parts of the world. This change has many manufacturers pushing to shift some practices back to pre-pandemic norms including a return to on-site inspections and audits. How can drug and devicemakers effectively merge the best practices for conducting on-site and virtual inspections?

FDAnews Announces — Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification Webinar Sponsored by ComplianceQuest July 8, 2021

FDAnews Announces Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification Webinar Sponsored by ComplianceQuest July 8, 2021 Share Article WCG FDAnews Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification Thursday, July 8, 2021 • 1:30 p.m. – 2:30 p.m. EDT Medical device regulations in the EU changed in major ways on May 26, 2021 with the implementation of the EU-MDR and bringing a device to market requires certification under these new expectations. Do you know the steps to take to get certified? Have you outlined your framework for minimizing delays? Are you prepared to make a concerted effort to collaborate on these issues?

FDAnews Announces — CBER s Five-Year Plan: Address the Agency s New Priorities and Stay Compliant in a Post-COVID-19 World Webinar July 13, 2021

FDAnews Announces CBER’s Five-Year Plan: Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World Webinar July 13, 2021 Share Article Ready to address CBER’s new priorities? Stay compliant: use innovative technologies to streamline supply chains, mitigate product shortages. WCG FDAnews CBER’s Five-Year Plan: An FDAnews Webinar Ready to address CBER’s new priorities? What it takes to stay compliant is changing… and this is how to stay ahead. One must incorporate advanced manufacturing processes and use machine learning (ML) and artificial intelligence (AI) along with real-world data (RWD) and real-world evidence (RWE). So says the CBER 2021-2025 Strategic Plan. Its goals require incorporating innovative technologies to more quickly develop safe and effective biologics.

FDAnews Announces Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives Webinar June 15, 2021

FDAnews Announces Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives Webinar June 15, 2021 Share Article Want to achieve all quality and business objectives? Quality culture is key: here’s how to create, sustain a healthy one. Register today. WCG FDAnews Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives An FDAnews Webinar How does one’s quality culture stack up? Products and compliance not to mention meeting business objectives depend on one that is healthy. Get a handle on how culture is created, shaped and changed with this webinar, so one can design and sustain a good quality culture within an organization.

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