Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Gottlieb Pledges Further Details About Testing Plan for Precertification Program
Unlike medical device software, health product software relates to maintaining or encouraging a healthy lifestyle.
FDA Clears Elite, SunGen’s Adderall Generic
The approval marks the fifth for Elite in 2018 with three ANDAs still pending.
QSR
RSS
ARTICLES
PRODUCTS
Sampling Plans for Quality Audits - Webinar Recording/Transcript
$287.00
Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. View
Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript
$287.00
The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report. View
Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript
$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View
The 510(k) Process - Webinar Recording/Transcript
$287.00
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View
Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript
$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View
Device Software Development: A Guide to Risk Management Requirements
$397.00
Device Software Development — based on a presentation by quality systems expert Dan O’Leary — is a comprehensive, point-by-point guide to developing software that meets all FDA and international standards for successful market clearance. View
Understanding ISO 19011:2018 - Webinar Recording/Transcript
$287.00
The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management. View
Medical Device Software and Risk Management - Webinar Recording/Transcript
$287.00
It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View
Surviving an MDSAP Inspection: A Guide for Devicemakers
$397.00
The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect. Surviving an MDSAP Inspection provides all the information you’ll need to understand the MDSAP model. View
Top Tips for Establishing Device Supplier Quality Metrics - Webinar Recording/Transcript
$287.00
You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View
Corporate Compliance & Liability - Webinar Recording/Transcript
$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View
Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript
$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View
