QSR

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How to Address Medical Device Sample Size Issues – Webinar Recording/ Transcript

$287.00
More 483s are being issued for violation of 21 CFR 820.200, statistical methods — most often for a lack of statistical justification for sampling plans. Design control statistical expert Steve Walfish is here to explain how to address your sample size issues. View

Develop World-Class SOPs that Minimize Human Error – Webinar Recording/Transcript

$287.00
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View

Medical Device Nonconforming Audit Findings – Webinar Recording/Transcript

$287.00
How should you respond to nonconformities from a notified body? Preparing your response can be daunting and can result in additional unnecessary efforts to your organization. View

Medical Device Warning Letters – Webinar Recording/Transcript

$287.00
Are you protected from the Forgotten Five most cited warning letter observations? If you’re not sure, you’re not alone. The Forgotten Five are not frequently discussed and have not generated much corrective information. In other words, the Forgotten Five are the highest-risk areas that offer you the most potential to prevent inspection issues. View

Transparency and the New Medical Device Reporting Rules – Webinar Recording/Transcript

$287.00
Do you have a handle on the changes you may have to make to your MDR program as a result of the Voluntary Malfunction Summary Reporting (VMSR) program? View

Using IT to Improve Data Integrity – Webinar Recording/Transcript

$287.00
Is IT a fully vested member of your data integrity team?  The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View

The AI Revolution – Webinar Recording/Transcript

$287.00
AI is changing the face of image analysis. How will the FDA keep pace with the evolving nature of these technologies while still ensuring that their safety and effectiveness are maintained? While there are still many issues the agency must work through, you need an understanding now of the FDA’s approaches to AI-based image analysis. View

Clarity on Clinical Investigations – Webinar Recording/Transcript

$287.00
The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View

Preparing for a MDSAP Audit – Webinar Recording/Transcript

$287.00
Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect. View

510(k) Change Analysis – Webinar Recording/Transcript

$287.00
The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes. View

Data Integrity – Webinar Recording/Transcript

$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

The EU-MDR Transition: Meeting the CE Mark Deadline

$397.00
The EU-MDR Transition: Meeting the CE Mark Deadline explains how to take advantage of the soft transition to the new regulation. The soft transition allows companies to retain certain aspects of the current CE Mark applications while following new registration requirements, if their notified bodies approve. View