Free FDA Compliance and cGMP Reports
Below are a number of free reports, articles and white papers on FDA compliance and cGMP guidelines. This list was updated in April 2013, and we add to it often, so please check back. Also, be sure to read our latest cGMP and FDA compliance news – updated daily. Bottom Line for FDA Compliance – […]
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5 Tips for Rock Solid Supplier Controls
Updated Daily – Read our latest FDA, cGMP Compliance News Are you in control of your medical device chain of supply to ensure quality? Here are five simple tips to help you to obtain better supplier control for the benefit of your patients, practitioners and employees: #1 Set Up Product/Service Quality Requirements During Design of […]
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More Counterfeit Drugs Pop Up – What to Do?
Updated Daily – Read our latest FDA, cGMP Compliance News Congress is currently mulling over a bill to provide better security to the drug supply, but we are seeing reports of still more counterfeit drugs coming onto the market. The latest is regarding an FDA alert about fake Botox, with the labels on the vials […]
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How to Optimize Your Quality System To Ensure FDA and ISO Compliance
Updated Daily – Read our latest FDA, cGMP Compliance News So what does cGMP quality cost? Many pharmaceutical companies would have a hard time defining quality in terms of dollars. However, what everyone DOES know is that poor quality can cost you millions in terms of a warning letter clean up or even a consent […]
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3 More Tips for Excellent cGMP Plant Design
Updated Daily – Read our latest FDA, cGMP Compliance News We ran a recent article about three tips for good cGMP plant design to so you can avoid 483s and other compliance problems. Here are 3 more helpful tips as you design your cGMP drug facility: #1 Design It To Be Clean Strong design means […]
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The Clock Is Ticking Part 2 – 15 Days To Respond to 483
Updated Daily – Read our latest FDA, cGMP Compliance News This is part 2 on our article detailing how to respond effectively to your FDA 483 within 15 days. It is also very helpful for a drug company to have a review of quality system management, or QSMR, during the 15 days you have to […]
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The Clock Is Ticking – Responding to FDA 483 in 15 Days
Updated Daily – Read our latest FDA, cGMP Compliance News When you respond to an FDA 483 for cGMP violations, you need to be sure that your response letter addresses each specific violation. Many companies will address the individual FDA complaints, but they never actually get down to a real solution to the problems. […]
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GMP Problems Result in 300 Jobs Chopped At Novartis Plant
Updated Daily – Read our latest FDA, cGMP Compliance News One way to deal with a 483 or warning letter for cGMP violations is to just chop operations. And that is exactly what Novartis is doing in Lincoln, Nebraska. About 18 months after Novartis admitted that it had major cGMP guideline problems at this […]
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Effective Project Management for Developing Medical Devices
Updated Daily – Read our latest FDA, cGMP Compliance News If your organization is developing a new medical device (21 CFR Part 820), you need to have effective project management. Below are some of the most important tips in our experience to ensure success of your medical device: #1 Always Under Promise and Overdeliver! Having […]
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4 Best Practices for Strong cGMP Plant Design
Updated Daily – Read our latest FDA, cGMP Compliance News Below are some of the most important aspects of designing a cGMP-compliant drug production facility. #1 Appropriate cGMP Layout A good cGMP plant layout has separate areas for the most critical functions of the facility. This is very important for any drug products that have […]
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