Quality

ARTICLES

EMA Issues Q&A on Health-Based Exposure Limits

The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Read More

FDA Issues Final Guidance on GMPs for APIs

The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization. Read More

PRODUCTS

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

FDA’s New Biosimilars Plan - Webinar Recording/Transcript

$287.00
To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market. FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know about the FDA’s Biosimilars Action Plan — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. View

Quality Metrics Redux - Webinar Recording/Transcript

$287.00
The FDA began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation. View

The CDER Reorganization: What It Means for Drugmakers - Webinar Recording/Transcript

$287.00
Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research. View

Pharmacy Compounding Regulation - Webinar Recording/Transcript

$287.00
What can you expect from the FDA’s 2018 Compounding Priorities Plan? View

GDP Audit Checklist: Meeting Global Transport and Storage Requirements

$230.00
GDP Audit Checklist: Meeting Global Transport and Storage Requirements is written by Simone Ferrante, Head of Quality & Regulatory Affairs for Grieshaber Logistics Group AG, Bad Säckingen. She implemented the company’s GDP/GMP-compliant quality management system. View

What CDER Can and Can’t Do: An Inside Look from an Agency Official - Webinar Recording/Transcript

$287.00
CDER, the FDA’s drug-approval arm, pays attention to patient and caregiver input … and so should you. Dr. Khatri shows you what CDER has done, what it wishes to do, and what law and regulation prevent it from doing. 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

Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

$287.00
Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it. View

Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View