Regulatory Affairs

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Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Supplier Contracts for Non-Lawyers - Webinar CD/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Stevens Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
NEW for 2017 — You’ll get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices. View

Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers

$397.00
Creating QSR-Compliant CAPA Systems provides you with a comprehensive knowledge of CAPA management that will help you avoid trouble. View

Investigations Operations Manual 2017

$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 2017. View

Top 5 Reasons to Use the Medical Device Single Audit Program - Webinar CD/Transcript

$287.00
The Medical Device Single Audit Program, or MDSAP, is skyrocketing in popularity as devicemakers discover its many advantages. Already 229 devicemakers have adopted it — 72 in this quarter alone. In just 90 minutes, Brian Ludovico of MDSAP Regulatory Certification will show you how to begin your MDSAP participation. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






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Detecting Trends in Medical Device Complaints - Webinar CD/Transcript

$287.00
When device users complain, those complaints must be passed on – to the FDA, the EU and other regulators. The FDA’s QSR. International standards ISO 13485:2003 and ISO 13485:2016 ... The EU Vigilance system and the draft EU Medical Device Directive (MDR) ... Couldn’t you use help with your complaint reporting systems? View

Seven Steps to Successful Medical Device Reimbursement

$397.00
Order Seven Steps to Successful Medical Device Reimbursement for an overview of the regulatory and reimbursement processes and how they fit together. View

Industry Trends and Best Practices for the Cleanroom Environment - Webinar CD/Transcript

$287.00
Cleanrooms are complicated. Product selection, rotating disinfectants, applying disinfectants and controlling bioburdens and residues are all part of the job. But what is the best way to handle it all? View

Dealing with Chinese Medical Device Regulatory Authorities - Webinar CD/Transcript

$287.00
To American eyes, the Chinese regulatory system is ... well, a Chinese puzzle. You can’t hope to get a registration approved without a knowledgeable and trustworthy local guide. Face it: You need expert help. And we’ve got just the expert to help you. View