Small farms across the United States have begun to express concern about impending FDA regulations. FDA consulting firms are likely to be sought by those who want to establish exactly where the proposed new regulations leave them. Is The FDA Pandering To The Big Boys Issues of favouritism are being suggested in relation to new [...]
Tags: FDA compliance, fda consulting, GMP training, pharmaceutical consultants, QP training
It goes without saying that conformity with the legislations that govern the pharmaceutical industry is essential and the medical device directive acts as a guideline to follow for those manufacturing medical devices. Understanding what is expected of them during the manufacture of medical products is essential for manufacturers and it is something that can only [...]
Tags: FDA compliance, medical device directive, medical device regulation, pharmaceutical consultants
The US Food and Drug Administration has announced that it will step-up its medical device regulation concerning healthcare machines which emit radiation. Over recent years there has been growing concern that there is not enough monitoring of the radiation equipment used on patients. There have also been episodes in the news when patients have been [...]
Tags: FDA compliance, medical device directive, medical device regulation, pharmaceutical consultants
It goes without saying that the governing bodies must be rigorous with their overseeing of the production of medical products and medical device regulation is something that all manufacturers need to be aware of. However, it is not always easy for manufacturers to stay on top of the latest regulations that govern the industry and [...]
Tags: FDA compliance, medical device directive, medical device regulation, pharmaceutical consultants
When a pharmaceutical manufacturing facility is subjected to an review or assessment, the matter of FDA compliance is likely to be one of the most pressing factors that will have to be tackled. Pharmaceutical consultants are more and more being sought after to offer guidance and help on what will be wanted from a manufacturing [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training
The US Food and Drug Administration is developing its control over externally manufactured drugs in a bid to reduce the number of substandard medicines which enter the American market. Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT is a way to control the drugs which enter at the border. Barcodes on cases of [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training
There are a lot of reasons why the pharmaceutical industry has to be so closely governed and Good Manufacturing Practice (GMP) auditing is one of the main ways it is governed. Surviving a GMP audit is something which is usually much easier to accomplish with the expert knowledge of pharmaceutical consultants readily accessible. GMP auditing [...]
Tags: FDA compliance, GMP auditing, GMP training, pharmaceutical consultants, QP training
The border control policy of the US Food and Drug Administration is being developed in an attempt to cut the number of poor standard medicines which enter the country from outside. The new initiative which is called PREDICT – Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting – will be a border-based scheme which assesses [...]
Tags: FDA auditing, FDA compliance, GMP auditing, pharmaceutical consultants, QP training
GMP consultants are mainly used to aid pharmaceutical companies in guaranteeing FDA and GMP compliance and will advise their clients of the kind of factors which can be considered to help guarantee this conformity. One of the most up-to-date features which countless GMP consultants may recommend to their clients is a kind of high efficiency [...]
Tags: FDA compliance, GMP auditing, GMP consultants, pharmaceutical consultants, QP training
There are a lot of factors why the pharmaceutical sector has to be so closely governed and Good Manufacturing Practice (GMP) auditing is one of the main ways it is ruled. Surviving a GMP audit is something which is usually much simpler to achieve with the qualified expertise of pharmaceutical consultants readily accessible. GMP auditing [...]
Tags: FDA compliance, GMP auditing, GMP training, pharmaceutical consultants, QP training