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Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Health Canada Opens Consultation on ‘Pause the Clock’ Proposal
The agency would be able to pause the clock for medical device applications linked together that have different review times.
FDA Approves First Immuno-Oncology Drug for Certain Patients Previously Treated for Lung Cancer
The agency said continuing approval for Opdivo may depend on the drug showing clinical benefit in future clinical trials.
Submissions and Approvals
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Top Tips for Establishing Device Supplier Quality Metrics - Webinar Recording/Transcript
$287.00
You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View
Corporate Compliance & Liability - Webinar Recording/Transcript
$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View
Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript
$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View
MDR Adverse Event Codes for Devicemakers - Webinar Recording/Transcript
$287.00
What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A. What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter. View
Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript
$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View
Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript
$287.00
Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details — and some of those details start taking effect next month. It’s time you got up to speed. View
Real World Evidence and the NEST Program: An FDA Perspective - Webinar Recording/Transcript
$287.00
The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you. View
Investigations Operations Manual 2018
$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View
Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript
$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View
Top Tips for Dealing with the FDA - Webinar Recording/Transcript
$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View
CDRH Reorganized: New Strategies for Devicemakers
$397.00
CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock. View