Quality

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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

Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and…

$397.00
Drugmaker’s Guide to ASTM E2500 explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations. 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

Supplier Contracts for Non-Lawyers - Webinar CD/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Stevens Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View

Internal Auditing Basics: A Guide for Drug and Device Manufacturers

$177.00
Internal Auditing Basics: A Guide for Drug and Device Manufacturers demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements. View

Investigations Operations Manual 2017

$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 2017. View