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

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

Real-World Serialization in Life Sciences — 2018 - Webinar Recording/Transcript

$287.00
The FDA is now regulating serialization under the Drug Supply Chain Security Act (DSCSA). And the FDA is not alone: Regulators worldwide, from Brazil and Argentina to South Korea and Saudi Arabia, are adding scrutiny of their own. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View

FDA’s New Concept of Operations for Drug Inspections & Evaluations - Webinar Recording/ Transcript

$287.00
ConOps is the acronym for a soon-to-take-place FDA restructuring that’s certain to affect drug inspections going forward. How will the agency’s new vertically integrated, programmatically aligned environment affect the new roles and responsibilities of CDER and ORA? View

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

Online Pharmacies — Impact on Regulatory & Quality - Webinar Recording/Transcript

$287.00
Websites selling junk drugs threaten the entire ethical drug business — manufacturers, suppliers, shippers, vendors, caregivers and patients too. It’s up to you to defend yourself. But how? View