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.www.articlesnatch.com/blog/Fda-Center-For-Drug-Evaluation-And-Research–cder-/6459481 Mettler Toledo Advises How To Avoid Out Of Specification Results Posted By: Mettler Toledo Mettler-Toledo today announced an upcoming webinar entitled "Avoid Out-of-Specification (OOS) Results: Weighing and Sample Prep Tips", featuring guest presenter Mr. Edward Szczesny, Senior Quality Specialist at Rhodes Pharmaceuticals L.P. In this free educational webinar, analytical and quality laboratory managers andprofessionalswho are concerned with reducing variability and avoiding potential errors in weighing and sample preparation processes, will learn aboutthe latest developments to tackle challenges such as: electrostatic effects on weighing; variability of manual sample preparation in a volumetric flask; and data traceability. Out-of-specification (OOS) and aberrant results are still a big concern for analytical and quality assurance and quality control QA/QC laboratories in the pharmaceuticalindustry. Any sample that does not meet the required standards or acceptance criteria is classified as an OOS result. The US Food and Drug Administration (FDA) regulations dictate that this must be followed up thoroughly with an investigation into the cause of the result. OOS investigations have a big impact on laboratory time and resources; therefore, any error is costly. Analytical balances are at the heart of almost all quantitative analysis that occurs in regulated or unregulated laboratories. Accurate weighing and data integrity are essential in the preparation of analytical sample or standard solutions.
quality assurance weighing Fdanews Announced Device Supplier Controls Virtual Conference, Feb. 26 Posted By: Sydney Hardison Falls Church, VA, February 08, 2014 – Device Supplier Controls Does the FDA’s Next 483 Have Your Name on It? **FDAnews Virtual Conference** Feb. 26, 2014 – 10:00 a.m. – 4:00 p.m. EST .www.fdanews.com/DeviceSupplierVC The medical device industry is struggling, with a forecast of single-digit overall growth for 2014. To cope with that, devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability. The unintended consequence? A much, much greater risk of supplier control violations. After all, the more suppliers you have, the more opportunities you give the FDA to find fault with your operations. Some devicemakers say they have as many as 400 outsourced contract manufacturers and suppliers. It’s no surprise, then, that it has become increasingly difficult to manage them and be sure that all raw materials, finished products and services meet the devicemaker’s required specifications as well as comply with FDA regulations. This FDAnews virtual conference is designed especially to take the headaches out of working with an ever increasing number of suppliers.
GCL FDANEWS Ecigarette Etiquette – The 9 Laws Of Vaping Etiquette Posted By: Daren With the possibilities of FDA regulations hanging over our heads, and other countries already putting controls in place for electronic cigarettes, vapers need to pay close attention to how they use their devices and where they vape. It essentially comes down to being a good steward and a decent individual. When talking about ecigarette etiquette, I’vee had discussions with people that run the gamut from far left to far right. In many cases, vapers firmly believe that since it’s not smoking it doesn’t fall under the laws governing tobacco use in public places. So they vape when and where they want, as often as they want. The continued rise in popularity of ecigarettes means they’re appearing more and more in public places. As we breach the general population and heads begin to turn, opinions will start to form among non-smokers (both good and bad) about vaping. So do we partake in our vapor as we see fit because we’re not doing harm to others, or do we practice good etiquette to put vaping in as positive a light as possible?
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Online Regulatory Compliance Online Regulatory Compliance A Lucrative Market For Sports Nutrition Ingredient Suppliers Posted By: saint joseph The competency of a Sports nutrition manufacturer lies in their ability to provide nutritional supplements targeted to achieve a specific goal. For instance, in order to improve their performance at a certain game, some athletes may require greater endurance levels, while others may look for faster weight loss, leaner muscles, greater flexibility and agility, faster recovery time etc. Sports Nutrition Ingredient Suppliers Dietary supplements provided by sports nutrition ingredient suppliers are regulated by the Food and Drug administration and as such the products are free from any kind of harmful substances or adulterants such as steroids. The chemical composition of performance enhancing supplements offered by sports nutrition ingredient suppliers are scientifically researched and are completely safe for consumption. The nutrients included are a blend of scientifically authenticated ingredients such as protein derived from whey or soy, ribose, essential amino acids etc. Reasons behind the success of a Sports Nutrition Manufacturer A sports nutrition manufacturer may manufacture its products in a variety of forms ranging from drinks, capsules, bars, shakes, powder or gels etc. The sports market is a lucrative one and the reason why profits are in store for a sports nutrition manufacturer are many.
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