Posts Tagged ‘pharmaceutical consultants’

How Small Farms Could Turn To FDA Consulting Practices For Help

Proposed changes to FDA compliance rules have led to a heightened level of concern amongst small farm operators in the USA. FDA consulting firms will most likely be the first port of call for those small farm owners who want a more in depth understanding of what any proposed changes will mean for them.

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Ex-FDA lab director sees no specificity on retests in final OOS guidance.(William Ment, out-of-specification)(Brief Article): An article from: Validation Times

This digital document is an article from Validation Times, published by Washington Information Source on February 1, 2002. The length of the article is 893 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Ex-FDA lab director sees no specificity on retests in final OOS guidance.(William Ment, out-of-specification)(Brief Article)
Author: Kelly Huegel
Publication: Validation Times (Newsletter)
Date: February 1, 2002
Publisher: Washington Information Source
Volume: 4 Issue: 2 Page: NA

Article Type: Brief…

Ex-FDA lab director sees no specificity on retests in final OOS guidance.(William Ment, out-of-specification)(Brief Article): An article from: Validation Times

Is The FDA Pandering To The Big Boys

Many small farm operators feel that new FDA compliance regulations are geared towards helping the larger, corporate farms rather than independent producers of food. Finding a reliable FDA consulting firm, with a track record of measurable success, is likely to be the first step for any small farm operator concerned about what new regulations may mean for their continued manufacturing procedures.

One of the most noticeably challenging aspects of the manufacture of pharmaceutical products and food is keeping up to speed with the ever changing rules and regulations being imposed by governing bodies such as the FDA. It is clearly apparent that FDA consulting will be sought out by all sorts of food and pharmaceutical manufacturers over the next few months because of the ways in which the FDA continue to introduce new legislation.

Small farm owners are concerned that the FDA are more involved in the pharmaceutical industry and that their governance of the food production industry is not set up in such a way to be fair to farms of their size. FDA consulting is something which is increasingly becoming essential for both food and pharmaceutical manufacturers as the regulations governing the production of goods become ever more convoluted.

For any company involved in the production of food or pharmaceutical goods, the issue of FDA compliance is likely to be one that has caused them many headaches due to the regularity with which the regulations are altered. In order to be compliant, many pharmaceutical manufacturers will seek out their expertise of FDA consulting practices that are well versed in the provision of training courses for those anticipating GMP auditing in the near future.

Understanding Medical Device Regulation

The entire medical device industry is understandably heavily monitored and medical device regulation is central to ensuring that products are suitable for the marketplace. It is important to realise, however, that manufacturers may struggle to keep up to date with all the different legislation that permeates the pharmaceutical industry and using the services of pharma consulting companies is likely to be extremely beneficial.

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Medical Device Development: Regulation and Law

Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of…

Medical Device Development: Regulation and Law

Few pharmaceutical sectors generate revenue on a par with that of medical devices and billions are spent each year on the manufacture and sale of these products each year. It goes without saying that utilising experts in the field of medical device regulation will be hugely advantageous to manufacturers regardless of the size of the medical apparatus they are producing.

It is clearly apparent that there is a vast range of apparatus used in the healthcare profession, from simple syringes right the way through to life support machines, and it is crucial to be aware of medical device regulation no matter what type of apparatus is being manufactured.

When considering issues of medical device regulation, it is important to take into account the speed with which the pharmaceutical industry moves and how new technologies and production processes are constantly causing a re-evaluation of the guidelines that govern the manufacture of medical devices. With so many new advances being made in the world of pharmaceuticals, it is an industry which be problematic to regulate for a number of different reasons but it is important to have safeguards in place which help to ensure that any medical devices that reach the marketplace are suitable for use and don’t pose an unacceptable level of risk.

The importance of making sure that medical devices are safe for the market place is plain to see and any manufacturer who has concerns about compliance and medical device regulation, it is certainly a good idea to seek out the skills and expertise of a pharmaceutical consulting agency.

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