FDA Pharmaceutical and Medical Device Books
Published: January 2012 | Pages: 109 | Price: $377 | ISBN: 978-1-60004-269-0
No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.
Published: April 2011 | Pages: 564 | Price: $350 | ISBN: 1740-4975
Published by Euromed Communications, this up-to-date manual covers the entire spectrum of industrial pharmaceutical microbiology. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing, environmental monitoring and hazard analysis. With chapters written by more than 30 internationally recognized experts in the field, you’ll find clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharma microbiology.
Published: March 2011 | Pages: 25 | Price: $397 | ISBN: 978-1-60004-224-9
Whether you’re new to the quality profession or you’re a veteran looking to strengthen CAPA processes in today’s tougher enforcement climate, Principles of an Effective CAPA System: A Guide for Device and Drug Companies plugs you into best practices that help you avoid the investigation, documentation and corrective action mistakes that have landed so many other companies with warning letters.
Published: February 2011 | Pages: 27 | Price: $327 | ISBN: 978-1-60004-228-7
There’s no doubt that these new requirements will increase the regulatory burden on drug and biologics trial sponsors and investigators already laboring under a heavy load. That’s why the new special report Adverse Event Reporting for Drug and Biologics Trials is essential for busy executives involved in clinical trials and regulatory affairs.
Published: February 2011 | Pages: 23 | Price: $377 | ISBN: 978-1-60004-222-5
Root Cause Analysis for Drugmakers is based on the very latest FDA regulations as interpreted by the agency and the courts. And because it’s written in plain English, it’s suitable for new hires and novices as well as seasoned quality experts looking for a brush-up refresher course.
Published: February 2011 | Pages: 213 | Price: $397 | ISBN: 978-1-60004-216-4
FDA Pharma Manufacturing Essentials brings together tested and practical advice that tackles the most pressing issues a pharma executive faces ... all in one, high-level and comprehensive resource.
Published: January 2011 | Pages: 74 | Price: $1,500
China Pharmaceutical Regulatory Report 2011, the research report that gives you a thorough understanding of the Chinese regulatory structure governing the drug industry. You’ll get a complete discussion of the laws and regulations that govern the testing, product registration, manufacturing, importing, marketing and sales of pharmaceuticals. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with regulatory information and business strategies to develop Asian markets.
Published: December 2010 | Pages: 41 | Price: $397 | ISBN: 978-1-60004-214-0
As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately
The FDA’s New Focus on Part 11: How to Prepare for the FDA’s Tough, New Electronic Records Inspections
Published: September 2010 | Pages: 60 | Price: $377 | ISBN: 978-1-60004-124-2
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.
Published: August 2010 | Pages: 131 | Price: $377 | ISBN: 978-1-60004-198-3
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 …
Published: July 2010 | Pages: 280 | Price: $377 | ISBN: 978-1-60004-112-9
With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.
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.