EduQuest — a global team of FDA compliance experts headquartered near Washington, DC — has been providing advice, training and inspection tips to FDA-regulated companies worldwide since 1995. Founded by three former FDA investigators and policy-makers, EduQuest continues to share its expertise and…
For the regulated software and systems you use in your activities, consult this list — prepared by former FDA investigators at EduQuest (including EduQuest President Martin Browning, the co-author of Part 11) who have done thousands of computer system audits worldwide —…
Q: I’m preparing a plan for what to do when an inspector shows up at our site for our next FDA inspection, including who will be the contact person, what information to give the inspector at the start of the inspection,…
Here’s a checklist for root cause analysis prepared by the experts at EduQuest who have conducted hundreds of investigations of non-conformances, failures and deviations in drug and device manufacturing facilities throughout the world: √ Testing: Look for any Out-of-Specification (OOS) results that…
Change Control is an area where critical items often “fall through the cracks”, much to your detriment when an FDA inspector comes knocking or when you’re trying to identify the root cause of a product failure or deviation. Here are…
An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…
Proper management and follow-up of product complaints is one of the major stumbling blocks for FDA-regulated companies. Compare your existing Complaint Handling Procedures against this checklist of best practices: √ Define your complaint sources √ Decide how a complaint is…
What makes EduQuest’s FDA compliance training better than others? Experience and our ability to let you “peek behind FDA’s curtain”. Each course is taught by full-time, senior-level EduQuest staff with more than 20 years’ experience on both sides of the…
In proportion to their relatively short length, 21 CFR Part 11 and FDA’s Part 11 Scope and Application guidance generate a huge amount of confusion and questions from EduQuest’s clients. So we’ve developed the following Part 11 cheat-sheet to help you better understand compliance. When in…
To effectively prepare for a visit from FDA, you must learn to look at your operations through the eyes of an FDA inspector. For your computerized systems, some items FDA inspectors and investigators are trained to observe include: – Is…
