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

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

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

$287.00
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

Implementing Elemental Impurities Testing - Webinar CD/Transcript

$287.00
A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs. View

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

$397.00
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