QSR

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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

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

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

Biocompatibility for Medical Devices - Webinar CD/Transcript

$287.00
Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Device Accessories – Understanding and Implementing the Final Guidance - Webinar CD/Transcript

$287.00
On Dec. 30, 2016, the FDA-CDRH+CBER issued a final guidance document to describe accessories and — in certain cases — provide a classification pathway. Dan O’Leary explains the approach in the guidance document and gives you the tools you need to determine and document whether any of your products are an accessory. View

FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices - Webinar CD/Transcript

$287.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Nick Sikorski and Robert Mai — both of Deloitte & Touche LLP – Cyber Risk Services — for a discussion on the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. View

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$287.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript

$287.00
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. View