Simplifying Global Compliance
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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
Senators Question Digital Health Pre-Cert Program
The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states.
Pfizer Gets FDA Nod for Breast Cancer Drug
The agency based its approval on the results of a 431-patient trial.
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The 510(k) Process - Webinar Recording/Transcript
$287.00
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View
Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript
$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View
Understanding ISO 19011:2018 - Webinar Recording/Transcript
$287.00
The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management. View
De Novo Strategies for Getting Your Medical Device Approved - Webinar Recording/ Transcript
$287.00
Will de novo work for you? Don’t miss out on your chance to get a better insight into de novo’s requirements and timelines. View
Complying with Advertising & Promotion Requirements - Webinar Recording/Transcript
$287.00
From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. Take a crash course in dealing with this panoply of enforcers. View
Medical Device Software and Risk Management - Webinar Recording/Transcript
$287.00
It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View
Surviving an MDSAP Inspection: A Guide for Devicemakers
$397.00
The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect. Surviving an MDSAP Inspection provides all the information you’ll need to understand the MDSAP model. View
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
Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC
$397.00
Order your copy of Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC and know how to handle hot spots in advertising and promotion while avoiding warning letters and other enforcement actions. View