FDA Pharmaceutical and Medical Device Books
Published: March 2010 | Pages: 41 | Price: $377 | ISBN: 978-1-60004-106-8
Responding to FDA 483s spells out best practices for managing the post-inspection process so you don’t get callbacks from the FDA. Think of it as “483s for Dummies” — a plain-English step-by-step guide that goes beyond boilerplate advice and digs into specifics that help you fashion a top-quality response to your next Form 483.
Human Error Reduction: Techniques for Stronger CAPAs, Root Cause Analyses and Manufacturing Quality Improvement
Published: March 2010 | Pages: 33 | Price: $377 | ISBN: 978-1-60004-104-4
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.
Published: March 2010 | Pages: 64 | Price: $377 | ISBN: 978-1-60004-096-2
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.
Published: November 2009 | Pages: 27 | Price: $377 | ISBN: 978-1-60004-079-5
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.
Published: September 2009 | Pages: 45 | Price: $377 | ISBN: 978-1-60004-077-1
SOPs: A Guide to Writing and Maintaining Standard Operating Procedures is the indispensable guide for anyone involved in producing or maintaining these crucial documents.
Published: September 2009 | Pages: 43 | Price: $377 | ISBN: 978-1-60004-083-2
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.
Published: September 2009 | Pages: 125 | Price: $377 | ISBN: 978-1-60004-085-6
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.
Published: August 2009 | Pages: 76 | Price: $377 | ISBN: 978-1-60004-075-7
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.
Published: July 2009 | Pages: 198 | Price: $357 | ISBN: 978-1-60004-058-0
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.
Published: July 2009 | Pages: 170 | Price: $297 | ISBN: 978-1-60004-060-3
The Japanese Drug Approval Reference Guide, published by FDAnews in the U.S.A., is the Japanese government’s official English-language version of its rules on new-drug approvals. Not a word has been changed.
Published: June 2009 | Pages: 48 | Price: $357 | ISBN: 978-1-60004-054-2
A Sponsor’s Guide to Auditing IRBs: Detecting Deficiencies and Ensuring Best Practices is the one step-by-step management report that gives you the tools you need to determine if your IRBs are complying with federal regulations. With Congress threatening legislation that will fortify FDA and HHS oversight, you’ll need to act fast. Order your copy now to discover how to avoid an IRB compliance disaster once and for all.
Published: April 2009 | Pages: 120 | Price: $357 | ISBN: 978-1-60004-046-7
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.
Published: March 2009 | Pages: 61 | Price: $357 | ISBN: 978-1-60004-036-8
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!
Published: March 2009 | Pages: 34 | Price: $377 | ISBN: 978-1-60004-032-0
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.
Published: February 2009 | Pages: 124 | Price: $357 | ISBN: 978-1-60004-040-5
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.