GMPs

ARTICLES

FDA to Recognize GMP Inspections From Eight EU Countries

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

PRODUCTS

Precision Medicine: Challenging the Regulatory Landscape - Webinar Recording/Transcript

$287.00
“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge. View

Quality Management Essentials: Expert Advice on Building a Compliant System

$397.00
In this new report from FDAnews, top authorities in quality management give insight and advice on the features that make a system strong and effective. This collection of essays from five of the drug and device industry’s most knowledgeable practitioners illustrates exactly how to create or update a quality management system that hits all the right notes. View

Extractables and Leachables: 101 - Webinar Recording/Transcript

$287.00
Once confined to the fringes of FDA regulation, extractables and leachables are now in sharp focus. Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices. View

FDA Inspection Intelligence - Webinar Recording/Transcript

$287.00
Drug and biologics makers are facing increased scrutiny of data integrity as an energized FDA deploys new tools to empower inspectors and concerns rise over Forms 483 and warning letters. View

Lean Management to Improve Quality & Compliance - Webinar CD/Transcript

$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

How to Build A World-Class Audit Team - Webinar Recording/Transcript

$287.00
Meet Susan Schniepp. She’ll show you how to avoid warning letters ... maybe forever. The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud. View

European Drug Assessment Policy for Biological Medicine - Webinar Recording/ Transcript

$287.00
Biologics and chemical-based medicines are fundamentally different, nowhere so much as under CMC policy changes set forth recently by the EU. But savvy biologics makers are already seeing a double-barreled opportunity in the EU’s action — avoiding costly compliance errors while boosting sales in the bargain. View

Data Integrity in the EU: Requirements for Quality Management Systems

$397.00
You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in. View

Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

$197.00
Report includes two checklists that guide you through the process so that you don’t have to worry about missing any points or asking the wrong questions. View

The FDA Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

$287.00
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

$287.00
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

$287.00
In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View