510(k) Change Analysis - Webinar Recording/Transcript

On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View

Making Sense of IVD Regulation - Webinar Recording/Transcript

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result. View

CDRH in Transition: Navigating the New Culture of Quality

In CDRH in Transition: Navigating the New Culture of Quality he explains why compliance and quality don’t necessarily go hand-in-hand and how the center’s GMP inspections program intends to increasingly emphasize what a company is doing right over dinging them for what they’ve done wrong. View

Process Capability Indices for Medical Device Manufacturers - Webinar Recording/Transcript

In device manufacture, QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. Particularly tricky: calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and you’re well on your way to cleaner inspections. View

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View

Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript

In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

China’s Medical Device Regulations - Webinar CD/Transcript

China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers. The price is a familiar one: Compliance with China’s regulations. View

Equipment Design and Qualification: A Guide for Drug and Device Manufacturers

This report — authored by international GMP expert Thomas Peither and associates — describes how to create and qualify a design plan that will meet the manufacturing goals and regulators’ expectations. View

Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

If your medical devices incorporate software, they may be targets for cyber-crooks. It’s time you adopted a strategy to gain information, evaluate it, and take action — including regulatory responsibilities. This FDAnews presentation provides the regulatory information you need to stay compliant. View

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows you where design control and risk management requirements overlap so you can serve both with one integrated effort. View