No Need to Validate the Software in Design and Development? Wrong!
Recent FDA Compliance News You might be surprised how many professionals think that they don’t need to validate the software/automated test equipment in their design and development processes. This is not correct! If you are utilizing a software tool or any kind of automated test to do design or design verification OR validation, then the […]
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Most Common FDA 483 Violations for Medical Devices
Recent FDA Compliance News According to recent FDA CDRH information, the most common 483 violations in the medical device industry are the following: Corrective and preventive action procedures (CAPA) – CFR 820.100(a) Complaint procedures -Â CFR 820.198(a) Corrective and preventive action documentation – 820.100(b) Process validation – 820.75(a) Written MDR procedures – 803.17 Below are […]
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New FDA Warning Letters Point Out CAPA Flaws
Latest FDA and cGMP Compliance News FDA is focusing its cGMP and Quality System Regulation efforts on the midwest and abroad in a new wave of medical device warning letters. One of the companies that was hit this summer was Enraf-Nonius BV, which is a medical device company in the Netherlands, but doing business in […]
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FDA cGMP Inspections in US Getting More Intense
Latest FDA and cGMP Compliance News US FDA cGMP audits continue to be getting tougher, partially because the priorities of FDA and their definition of cGMPs continue to change. In past years, we have seen that QA managers in the pharmaceutical industry generally knew what they could inspect from an FDA audit. The inspections would […]
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Latest Trends in cGMP Compliance
Latest FDA and cGMP Compliance News Here are some current cGMP compliance trends we are hearing from some of our industry contacts. We are seeing in the last year or two an emboldened FDA, which is trying to measure up under a Congress more interested in food and drug safety. For example, we have seen […]
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6 Tips to Avoid 510(k) Submission Delays
We often get questions about how medical device companies can minimize delays with FDA in having their device cleared. Note that some delays are not in the hands of the submitter, but there are surely some easy steps that you can take that will streamline the 510(k) submission process. Here are some easy tips to […]
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Tips and Thoughts on Critical Process Cleaning Procedures
Latest FDA and cGMP Compliance News How hard can cleaning be? That is something that people who are not involved in the production of pharmaceutical products may ask, but not people in the industry. The general thought process in the industry is that cleaning and cleaning validation is a practice that is necessary and unpleasant […]
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No Device Complaints – No Problems? Think Again
Latest FDA and cGMP Compliance News FDA states that a complaint is any written, oral or electronic communication that is alleging there are deficiencies in a product related to the quality, durability, identity, safety, reliability, performance or effectiveness of a medical device after it is released to the market. Note that the ISO 13485 definition […]
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Tips to Qualify Your Pharmaceutical Ingredient Suppliers
Latest FDA and cGMP Compliance News As most of us know, the globalization of drug manufacturing and the move to the use of many overseas suppliers has greatly increased the complexity and vulnerability of the drug supply chain. That is why supplier and vendor cGMP compliance at all stages – purchasing, manufacturing and distribution […]
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Don’t Fight the FDA Auditor! FDA Issues Guidance on How to Avoid Inspection Problems
Latest FDA and cGMP Compliance News FDA has been ramping up its efforts to inspect drug facilities in the last three years or so. Some of the largest pharmaceutical companies have had cGMP inspectors at many of their sites. Drug compounding pharmacies are getting more scrutiny due to a very serious fungal meningitis scandal. FDA […]
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