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.

It’s all in Managing Clinical Investigator Compliance, the soon-to-be-released management report from FDAnews that brings you up to speed on the latest requirements for investigators.

Cleaning Validation: Strategies for Compliance goes beyond the regulations and digs into the real-life world of cleaning validation. Tips to create an effective master plan ... appropriate SOPs ... auditing for compliance ... practical solutions to troublesome cleaning validation challenges ... this timely volume help keep the FDA at bay, boost production efficiency, and fatten your bottom line.

SOPs: A Guide to Writing and Maintaining Standard Operating Procedures is the indispensable guide for anyone involved in producing or maintaining these crucial documents.

This all-new guide from FDAnews walks you through the steps of managing supplier audits, from initial contract negotiations ... to risk assessment ... to actual conduct of audits ... to documenting and preparing for FDA inspection.

This all-new report from FDAnews walks you through the steps that result in first-class supplier-quality agreements — documents that protect you and your customers from problems.

Most companies rely on change control forms to track changes and describe current states of control. Adopting and maintaining change control forms that work can be a quality manager’s greatest challenge. Taming the Change Control Beast: Creating and Maintaining Effective Change Control Forms is the indispensable management report for anyone involved in producing or maintaining these crucial documents.

Surviving a Japanese Medical Device Inspection is the one management report that will tell you exactly what to expect when Japanese inspectors arrive, how to prepare and manage the inspection process and ensure that inspectors leave happy and confident in your facility's compliance.

The EU Clinical Trials Regulatory Reference Guide is the essential manual that gives you an overview of the clinical trial laws and regulations from each of the 27 EU member countries. Before launching clinical trials in EU countries, know exactly what you’re getting into. This guide, painstakingly compiled by the editors of the newsletter Clinical Trials Advisor, reviews the requirements of each of the EU countries and includes web references and complete legislative and regulatory texts where available.

Now available from FDAnews, Managing Recalls for Compliance spells it all out for you — the ins and outs of what constitutes a product recall and what device manufacturers must do to comply with FDA regulatory requirements. From voluntary and mandatory recalls to recordkeeping, inspections and warning letter analysis, this information-packed management report guides you step-by-step through the issues and rules that cause the most confusion for devicemakers.

Now available from FDAnews, From 50 Document Management Systems to Three, this information-packed management report provides a step-by-step look at how Pfizer met hardware, software and change-management challenges to create a global document management system (GDMS). While migration involved multiple divisions and software releases, 10,000 users, 118 countries and 12 million documents, Pfizer’s strategy and implementation offer valuable insights for IT consolidation in companies of every size.