GMPs

ARTICLES

Chinese Heparin Testing Lab Warned by FDA

A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More

PRODUCTS

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

Global Regulation 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

Biosimilars Regulation: The Importance of Interchangeability - Webinar CD/Transcript

$287.00
The biosimilars industry is at a crossroads known as interchangeability. Drug and biologics firms that are first to master this key concept stand to reap the greatest rewards. View

The FDA’s New Inspection Practices: A Guide for Drugmakers

$397.00
The FDA’s New Inspection Practices: A Guide for Drugmakers explains the FDA’s plans for upgrading its inspectorate and provides the key resources you will need to prepare for your next inspection. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

$287.00
Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

$397.00
This report — authored by international GMP expert Thomas Peither and associates — lays out the basics of building a four-phase qualification plan… design qualification, installation qualification, operational qualification and performance qualification… that satisfies US and EU requirements. View

FDA’s Big 5 Challenges - Webinar CD/Transcript

$287.00
The FDA likely will break new ground this year, posing extraordinary regulatory challenges to Rx, food and tobacco interests. Botox. Cannabis. Opioids. Tobacco intended use. State right-to-try initiatives. How will the FDA tackle these hot potatoes? View