FDA Pharmaceutical and Medical Device Books
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.
Published: February 2009 | Pages: 55 | Price: $357 | ISBN: 978-1-60004-030-6
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.
Published: February 2009 | Pages: 33 | Price: $347 | ISBN: 978-1-60004-028-3
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.
Published: December 2008 | Pages: 120 | Price: $297 | ISBN: 978-1-60004-026-9
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.
Published: December 2008 | Pages: 120 | Price: $297 | ISBN: 978-1-60004-024-5
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.
Published: October 2008 | Pages: 127 | Price: $225 | ISBN: 978-1-60004-013-9
Risky Business: Managing the Quality of America’s Medicines focuses on the human elements — how quality processes happen and how people figure into that equation in both design and execution. Written from the perspective of a 30-year veteran of quality management, Robert Rhoades understands the challenges FDA-regulated industries face. He thoroughly explores the world of quality control and focuses on common problem areas.
Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More
Published: September 2008 | Pages: 25 | Price: $377 | ISBN: 978-1-60004-004-7
Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More is the management report that gives you the framework for reviewing your quality system to ensure conformity with ISO 13485, as well as tips for keeping your staff engaged in compliance. Plus, it includes the most commonly overlooked deficiencies that result in findings of nonconformance.
Published: September 2008 | Pages: 237 | Price: $497 | ISBN: 978-1-60004-006-1
Preparation and Maintenance of the IND Application in eCTD Format. Whether you’re still filing IND submissions in paper, or have filed electronically for a while, you’ll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions — and adding real-world case studies from ZymoGenetics and Epix — offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions.