FDA Pharmaceutical and Medical Device Books
Published: April 2013 | Pages: 640 | Price: $397 | ISBN: 978-1-60428-106-4
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!
Published: April 2013 | Pages: 189 | Price: $397 | ISBN: 978-1-60428-108-8
CAPA keeps confounding medical device manufacturers. For two years running, CAPA has spawned more device warning letters than any other regulatory issue. And 2013 is shaping up as just as bad as 2011-12 — or maybe even worse. CAPA’s reporting and recordkeeping demands are major headaches.How does the FDA define ‘well-written report’? How can devicemakers best justify the risk analysis used to support CAPA implementation decisions? How can devicemakers best evaluate CAPA filing systems for FDA compliance? This new one-of-a-kind report from FDAnews has the answers — and more …
Published: April 2013 | Price: $397
When one of your medical devices triggered a consumer complaint, you responded immediately. You dotted all the i’s and crossed all the t’s. You thought you’d taken every prescribed step. And still you got a warning letter. What went wrong? What you may not realize is that FDA scrutiny can probe every aspect of your operation — customer service, field servicing, sales, device reporting, CAPA, design change, corrections and removals, and more. You need a systemwide solution — one that turns your entire operation into a well-oiled complaint-handling machine. If you aren’t sure how to pull it off…
Published: April 2013 | Pages: 65 | Price: $397 | ISBN: 978-1-60428-104-0
This all-new report from FDAnews will help you perform a comprehensive gap analysis that assures your Site Master File matches your company‘s activities. In addition, readers will review up-to-date explanations and analysis of all the new Site Master File changes, a sample document illustrating what the newly overhauled Appendix 8 (Equipment and Devices for Production and Quality Control) of a Site Master File should look like and much more.
Published: April 2013 | Pages: 33 | Price: $397 | ISBN: 978-1-60428-102-6
Inspection Readiness takes you inside the FDA investigator’s mind. What motivates investigators? What do they look for? What telltale body language can give you away? You’ll discover guidance on how to train SMEs for Inspection Day, plus learn about three case studies — based on actual investigations — that show how things operate in the real world.
Published: April 2013 | Pages: 55 | Price: $397 | ISBN: 978-1-60428-100-2
Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes. Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.
Published: March 2013 | Price: $595
At its heart, our industry is about saving and improving lives. That’s what draws people into this business in the first place. But sometimes people need reminding about that. That’s what this classic training DVDs has been doing for years, with powerful stories that remind people exactly how GMP compliance affects real life.
Published: March 2013 | Price: $595
You’ll Soon Feel Better was produced for the Association of British Pharmaceutical Industries (ABPI) in 1987 to highlight what can happen when GMPs are not followed. The program is divided into three stories that viewers will relate to.
Published: March 2013 | Price: $595
To a new employee — and even some veterans — the FDA is a mystery: Part cop, part scientist and part politician. But it’s the most important agency you, as a newcomer to the industry, will ever deal with. Wouldn’t it be a good idea to know how the agency really works?
Published: March 2013 | Price: $997
Ever want to take your employees inside an FDA inspection interview to show them exactly what can go wrong — and how to avoid these mistakes? Sitting across the table from any regulatory inspector is one of your employees’ most nerve-wracking challenges, even for experienced employees. Now you can give them the confidence they need with a new eLearning course.
Published: March 2013 | Price: $2,997
Imagine you could look over the shoulders of your company’s employees. Just as they are about to make a mistake, you whisper the right decision in their ear. The fact is, you can’t be on the manufacturing floor, in the labs or control rooms where people face the decisions that will test their training. But you can give them the reinforcement they need to make the right decisions with this six-lesson eLearning package.
Published: March 2013 | Pages: 295 | Price: $397 | ISBN: 978-1-60428-092-0
Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. What’s a supplement manufacturer to do? Get up to speed — fast. Take an FDA crash course. How do inspections work? What does the agency expect in document compliance? Which GMP mistakes are most likely to be targeted? Luckily, help is now at hand.
Published: March 2013 | Price: $597
In more than 10 years running the Clinical Trials Centre at the University of Hong Kong, Johan Karlberg, MD, PhD, BSc, helped manage more than 640 sponsored trials, and he witnessed all the hurdles that can trip up trial sites. More GCP training, he concluded, is not the answer to the problems the sites faced. What they needed was a simple mechanism to bring themselves into compliance with GCP regulations and best practices. And the Clinical Trials Magnifier Clinical Trial Site SOPs were born.
Published: March 2013 | Pages: 207 | Price: $397 | ISBN: 978-1-60428-098-2
When the FDA investigator reviews your records, will you be able to demonstrate the integrity and security of all the Excel spreadsheets your organization depends on? Make sure the answer is “yes” — with this definitive work on FDA spreadsheet compliance now updated for 2013 ...
Published: February 2013 | Pages: 362 | Price: $387 | ISBN: 978-1-60428-087-6
International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections. Many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results. And in many countries, drug safety concerns are prompting new requirements. You learn the new rules of the game, or cede the playing field to competitors. That’s where the FDAnews Guide to International Pharma Regulation: 2013 Edition comes in.