FDA Sets May 11 Hearing on Recent Biosimilars Guidance

Upcoming Events

Dietary Supplement GMP Inspectional Readiness:
A Comprehensive Road Map To 21 CFR 111
An FDAnews Virtual Conference Read More
Device History Records
Sec. 820.184: FDA Inspectors Are Reviewing Them Carefully — Are You?
An FDAnews Webinar Read More
Medical Device Risk Management
Beyond FMEA — New Tools To Assure Your Risk Management Program Meets New Standards
Boston, MA Read More
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Resource Center

Conducting Bulletproof CAPA Investigations — ADVANCED
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today. Read More
Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today. Read More
Surviving an FDA Inspection
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! Read More

Washington Drug Letter