The FDA leaves it to you to determine supplier risk and reliability, via audits that you conduct. But make a wrong call and you could face a Form 483, a warning letter or, even worse, liability lawsuits. So here’s the question of the day: Are you doing your best job on audits? If the answer is no … or even maybe … get timely help from FDAnews.

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.

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 Drugs today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for drugs for 2013 with all of the FDA rules for drugs 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.

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!

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…

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.

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.