Commercial Operations



Medical Device Supplier Quality Management - Webinar CD/Transcript

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

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

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

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

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

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

Successful Collaboration with Your Sales and Marketing Team - Webinar CD/Transcript

Do you need a better working relationship between Regulatory Affair and your sales and marketing teams? Hear directly from an expert who has personally facilitated communication between these two groups. Join Katy Van Pelt — Partner, Potomac Law Group — for a 20-minute presentation, followed by a 30-minute one-on-one interview conducted by moderator Michael Levin-Epstein. View

Reduce Human Error in Drug and Device Manufacturing - Webinar CD/Transcript

What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. View

Conducting a Connected Medical Device Security Risk Assessment - Webinar CD/Transcript

How should you conduct a risk assessment for your connected medical devices? Security risk specialists Russel Jones and Nick Sikorksi — both with Deloitte & Touche — discuss how security risk assessments need to be conducted and how to develop remediations to reduce risks to an acceptable level. View

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View

Digital Innovation - Webinar CD/Transcript

It’s pretty clear that digital medical devices are transforming into information appliances connected to information systems, creating tons of new opportunities and even more challenges. Tim Gee — Principal and Founder of Medical Connectivity Consulting — provides insight into the regulatory landscape and recommendations for going forward. View

The Most Important Legal Cases Regulatory Affairs Specialists Absolutely Must Understand - Webinar CD/Transcript

Legal expert William Janssen — Professor of Law, Charleston Law School — provides a practical explaination of recent key decisions that affect what regulatory affairs does every day, in ways you may not have realized before.  View