Regulatory Affairs

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ICH Stability Requirements - Webinar CD/Transcript

$287.00
Compliance with ICH stability requirements is a necessary step in getting your new drugs approved. Yet drugmakers routinely give it short shrift — to their sorrow. 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

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

$230.00
GMP Inspection Preparation Checklist: A Tool for Internal Auditing includes more than 650 items organized in three sections covering all aspects of quality manufacturing. View

Good Clinical Practices: The New ICH E6 Standard

$397.00
Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. View

Develop a Process Validation Roadmap - Webinar CD/Transcript

$287.00
A QA/QC expert has come up with a “roadmap” to steer you through the FDA’s complex of steps and guidelines surrounding process validation. View

Disinfectant Testing and Validation - Webinar CD/Transcript

$287.00
Keeping cleanrooms clean takes more than soap and water. A lot more. It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. View

Impact: FDA User Fees, Drug Competition and Pricing - Webinar CD/Transcript

$287.00
User fees affect drug competition at every level. And user fees are set to rise. Top-level meetings are under way at the FDA, the White House and in Congress. Policy is being hammered out amid great uncertainty under a new FDA administrator, Scott Gottlieb and a new White House that boasts no special background in drug policy or regulation. View

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Best Practices in Food Process Labeling & Regulation - Webinar CD/Transcript

$287.00
A strong health claim can send your products flying off the shelves. But go too far and you risk sanctions from the FDA, FTC and USDA to state and local health departments, not to mention the ire of consumer groups and their well-paid lawyers. Here’s how to stay on the safe side of the line. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View