This instructional guide and DVD creates a powerful, hour-long training event that shows employees the types of questions and tactics they’ll face during inspection, and gives them the confidence to respond correctly. Order Today.

When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies? Discover the answers — and more — in a new management report from FDAnews.

Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, new FDAnews survey of devicemakers.

This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sites in the months ahead.

Just released from FDAnews — Investigations Operations Manual 2012 — the FDA’s own internal guidance on how to inspect a drug or device company.

No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.

The FDA originally videotaped these 10 training sessions — more than eight hours’ worth — to train its own staff in quality training. Now FDAnews has brought all 10 sessions together on one convenient, affordable DVD, designed to give you the kind of high-level employee education everyone wants … with the flexibility that makes in-house training most beneficial.

Whether you’re new to the quality profession or you’re a veteran looking to strengthen CAPA processes in today’s tougher enforcement climate, Principles of an Effective CAPA System: A Guide for Device and Drug Companies plugs you into best practices that help you avoid the investigation, documentation and corrective action mistakes that have landed so many other companies with warning letters.

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately

Medical Device Complaint Management: A Guide for Compliance provides a complete explanation to help you comply with FDA requirements.

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures.

Despite years of harmonization talks, the EU and US still follow very different marketing approval processes for medical devices. And when the EU’s MDD went into effect in 2010, those differences became more pronounced. Failing to know the differences could critically handicap your time to market and ability to operate efficiently. Failing to comply with those differences could shut you out of EU markets completely.

Do you prepare your medical device facility for an FDA inspection the same way you did last year — or even six months ago? If you do, you could be in big trouble. The rules of the game have changed and the FDA is cracking down harder than ever before … and it’s only going to get worse.

Attention drug and device manufacturers — the new health reform law is about to turn your marketing world upside down. Under new rules, companies like yours must begin collecting data about payments to physicians. And that’s just the tip of the iceberg …

Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems. You are now expected to trend your quality data.