FDA Pharmaceutical and Medical Device Books
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: 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: 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: 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: 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: 978-1-60004-024-5
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.
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.
Published: August 2008 | Pages: 29 | Price: $397 | ISBN: 978-1-60004-007-8
Managing Supply Chain Risks: Meeting FDA Expectations is the management report that will help you select, audit and monitor outsourcing partners to ensure quality problems are contained and harmful products don’t reach patients. The FDA already has considerable authority to enforce its quality regulations up and down the supply chain. But in the past, it has lacked the resources. In the last six months, that has started to change with increased funding for inspections. And next year, it's likely to change even more as Congress puts together new laws designed to enhance enforcement activities and reach deeper into the supply chain to ferret out potential problems.
Published: July 2008 | Pages: 197 | Price: $337 | ISBN: 978-1-60004-002-3
Tune Up Your CAPA System: A Practical Guide, the management report that will take you through the latest trends in FDA CAPA enforcement, highlight the deficiencies that inspectors are finding and offer you insight into where you should look to determine the effectiveness of your CAPA systems. This management report includes an expert analysis of real-life warning letters and a step-by-step guide to what the FDA looks for when it inspects your CAPA system. Plus, you’ll get a list of best practices to make sure your system can stand up to the agency’s scrutiny.