Commercial Operations

ARTICLES

PRODUCTS

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

The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

How to Integrate FDA Device Approval and Reimbursement - Webinar CD/Transcript

$287.00
Join Steve Terman — Principal Attorney, Olson Frank Weeda Terman Matz — and Gordon Schatz — President, Schatz Reimbursement Strategies — as they explain how to strategically blend reimbursement with FDA regulatory issues and identify the need for outcomes data, comparative evidence, professional society guidelines and how to meet Medicare and managed care reimbursement standards. 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

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

Medical Device Supplier Quality Management - Webinar CD/Transcript

$287.00
Purchasing controls and supplier management continue to be target-rich environments for FDA investigators. Join expert Jim Shore — Director of Quality at Titan Medical, Inc. — for an overview and up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices. View

China Medical Device Regulatory Changes - Webinar CD/Transcript

$287.00
If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there. This session will cover developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. View

New Trump Administration, New Republican Congress - Webinar CD/Transcript

$287.00
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

False Claims Act Liability: A Guide for Drug and Device Manufacturers

$397.00
The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen. View

Effective and Efficient Medical Device Recalls - Webinar CD/Transcript

$287.00
You can’t afford to make mistakes during a recall. Join Willie Bryant and Chris Harvey — both of Stericycle ExpertSOLUTIONS for a discussion on how to assess your current recall plans to see if they’ll really work when you put them into action. View

How Does Cybersecurity Fit in Your QMS? - Webinar CD/Transcript

$287.00
Learn the best practices for integrating medical security processes with the organization’s QMS and the ongoing role of Quality in securing connected medical devices. View