Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
FDA Approves Contact Lens for Myopia in Children
The lens focus light on the back of the eye, which is believed to reduce progression of the condition.
HHS Hits Gilead With Patent Infringement Suit Over PrEP Drugs
Truvada was approved in 2012 for use as a PreP regimen, and Descovy was approved in October 2019 as a PrEP regimen.
Quality
RSS
ARTICLES
PRODUCTS
Increase Compliance, Reduce Risk with Integrated Digital Solutions – Webinar Recording/ Transcript
$287.00
Your connected technology — the integration of your electronic document management, training management, risk mitigation, risk management, deviation and CAPA management, and audit management systems — will trigger the kinds of checks and balances across systems that increase compliance and reduce risk. View
FDA 483s, Warning Letters & Enforcement Trends – Webinar Recording/Transcript
$287.00
How should you prepare for your next inspection? The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP. View
Understanding UDI in EU Device Regulations – Webinar Recording/Transcript
$287.00
EU device regs are an ongoing compliance headache but one thorny issue — UDI compliance deadlines for Class I and unclassified devices — is upcoming. When next May rolls around, will you be ready? View
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 Product Off-Label Use and Marketing – Webinar Recording/Transcript
$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. 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
