QSR

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Device Accessories – Understanding and Implementing the Final Guidance

$187.00
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

$187.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Russell L. Jones and Nick Sikorski — both of Deloitte & Touche LLP, Life Sciences & Healthcare Sector – 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

$187.00
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

Using the E2500 Approach to Validate Equipment, Utilities and Facilities - Webinar CD/Transcript

$187.00
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

Corrections, Removals and Recalls: A Guide for Devicemakers

$177.00
The Corrections, Removals and Recalls: A Guide for Devicemakers brief sorts it all out for you, defining the key terms and parsing the FDA regulations that govern corrections, removals and recalls. View

New Medical Device and In Vitro Diagnostic Regulation in the EU - Webinar CD/Transcript

$287.00
Join Michael M. Gaba — Life Science Partner, Holland & Knight LLP, USA — and Shayesteh Fürst-Ladani — founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland — for a discussion on the biggest anticipated changes to the EU and U.S. medical device framework and their impact on global go to market strategies, including the extent to which a company can harmonize its regulatory effort for the global market. View

Corrective Action & Preventive Action for Medical Devices - Webinar CD/Transcript

$287.00
Join industry expert Dan O’Leary as he identifies the most frequently cited steps in the corrective and preventive action processes, explains the issues that warning letters reveal and provides information to avoid these problems. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

Device Documentation: A Guide to Managing Four Critical Production Files

$177.00
With Device Documentation: A Guide to Managing Four Critical Production Files you will learn about the required elements in the Device Master Record (DMR), the source of the Device Master Record, the required elements in the Device History Record (DHR) and more. View

Three Phases of QSR-Compliant Equipment Control

$177.00
The next time you walk the manufacturing floor, think about how many pieces of equipment you use for production, how many moving parts they have, and all the ways things could go terribly wrong. View

The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript

$287.00
The passage of the 21st Century Cures Act means you will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. View