Problems with equipment maintenance, cleaning and calibration are among the FDA’s most commonly observed deficiencies. If you want to avoid these issues and reduce risk you need this report. This authoritative management report offers a comprehensive analysis of the FDA’s regulatory requirements — and more importantly, strategies for complying and reducing risk while saving time and money.

With mere weeks remaining until the FDA’s new cGMP rules kick in, many drug, biologics and device manufacturers remain unclear about how to comply. The rules, made final in January, affect every combination product — not a single one is “grandfathered.” They require you not only to review your manufacturing procedures — particularly when different constituent parts are made at separate facilities — but also to review and/or modify SOPs, review and/or modify QC/QA systems, institute new employee training programs and protocols, and make top-to-bottom reviews of dozens of internal processes. It’s a tall order, and time is short. Fortunately, help is at hand.

Don’t take a chance with contamination – or compliance. In just 20 minutes, anyone in your company can be trained or be refreshed in proper cleanroom behavior. Order Correct Behavior in the Cleanroom – eLearning Edition and your employees and contractors, experienced and new, will learn the purposes and functionality of cleanroom equipment, what not to do in a cleanroom and why, critically important behaviors recommended for cleanrooms and much more.

Stay up to date on more than two dozen key medical device regulation changes with the 2013 edition of FDAnews’ Guide to Medical Device Regulations — the most authoritative and comprehensive guide ever assembled. Order it now to understand what your organization must do to satisfy the FDA and achieve success.

Behind every successful FDA inspection lies a well-run “war room” — the place where key personnel meet to respond to FDA inspectors’ requests, prepare requested documents, and monitor inspection progress. Because the FDA inspector could knock tomorrow morning, an up-to-date war room is essential. Yet far too many drug- and devicemakers neglect to keep their war rooms up to date. Some haven’t even set up one yet. How long has it been since you checked the status of your war room? If you aren’t sure, check out this timely solution from FDAnews.

China is about to become the world’s second-largest medical device market — is your company fully prepared to cash in? Map your success in this lucrative market with the Latest Guide to Chinese Medical Device GMP Regulations — 2013 Edition. Order it now to learn the simplest way to set up Chins-compliant management and adverse event reporting systems, understand processes and criteria used in inspections of manufacturers seeking access to the Chinese market and more.

Order your Two-Volume Devices/Diagnostics Title 21 CFR Set today! The federal government has just compiled the new devices/diagnostics-related Title 21 CFR volumes for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

Order your Two-Volume Clinical Trials Title 21 CFR Set for Devices today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for devices for 2013 with all of the FDA rules for devices updated through April 1, 2013.

Order your Three-Volume Clinical Trials Title 21 CFR Sets today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

Order your individual Title 21 CFRs today! The federal government has just compiled the new Title 21 CFRs for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

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 …

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…

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.

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 ...