Drug manufacturers: Be careful what you wish for. For years, drugmakers have urged the FDA to revisit 21 CFR Part 11, which governs electronic records. Now the FDA has done so — and the industry faces new compliance burdens.

If you are involved in the manufacture of drugs or biologics, including contract manufacture — in quality, compliance or regulatory affairs — Human Error Reduction is a must-read report.

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.

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.

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.

Place your order today for this management report from FDAnews — FDA Advertising and Marketing Enforcement Update: What a Newly Reenergized DDMAC Means to You. Essential reading for all marketing and regulatory affairs professionals — and for key members of your promotional materials review team — this three‑in‑one management report gives you fingertip-access to the latest DDMAC enforcement trends, an anytime “refresher course” on the basics of DDMAC compliance, and protection against future warning letters with a special “enforcement trend forecast” for 2009!

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, an information-packed management report that reveals how to beat the most common problems that pharmaceutical and device companies face when implementing enterprise resource planning (ERP) systems. Managing Quality and Compliance in ERP System Migration and Implementation provides expert guidance and advice to make your next project a smooth one. It offers insights on project schedule planning; adopting "look-ahead" management techniques; balancing time, cost and quality; designing FDA-compliant validation into the system and much more.

Now available from FDAnews, this information-packed management report maps out exactly what the new joint inspections mean to your facility — and what you must do now to prepare. Step by step, you’ll learn how to troubleshoot potential problems and align GMPs with both FDA and international rules.

Japanese Medical Device Inspection Guide, the working English translations of Japanese GMP regulations and guidances. This 120-page manual is all you need to ensure your facility can handle the scrutiny of a PMDA inspection.

Japanese Pharmaceuticals Inspection Guide is your single source for Japanese GMP regulations and guidances — all translated into English and published by the PMDA — and the resource you need to make your next PMDA inspection successful.