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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.



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.

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?






ejuice Marketing Fda Regulated Products Through Social Media Posted By: Compliance Trainings Description : The seminar will discuss the do"s and don"ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via social media, hence it is prudent to familiarize with the current processes and plan for developments expected in the near future. Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA. This is hard with social media outlets where information can quickly get out of hand and lead to violation of FDA regulations, and possible penalties on the manufacturers. The FDA recently held hearings addressing drug companies’ use of social media and other online platforms to advertise. FDA also released a guidance document about manufacturers" obligation regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition, FDA issued several letters to manufacturers indicating the rules for using social media.



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Food Facility Registration The Stop Smoking Injection: Why Not Take Your Shot Posted By: Christopher Irwin If you’re trying to stop smoking on your own, or if you’ve tried other smoking-cessation products that just didn’t work, it’s possible that the GottaKickit application may be just what you need. Take a week or two for yourself to come to one cigarette a day. To avoid this, stop smoking gradually. Many people say that after the shot their cigarette desire simply disappears. If you have any more suggestions and tips on quitting smoking you can share them with us. The side effects related to nicotine overdose include chest pain, irregular heartbeat, nausea, vomiting, along with dizziness, blurring of vision and seizures. These symptoms need to be treated as an addiction in order to be treated effectively. In this way, the individual has received individualized training and therapy by a licensed therapist first, and when he just needs support, he can use the quit smoking hypnosis videos to help remind him of all the techniques that he learned in the sessions. This problem can be solved by appropriate intake of Gotu kola which is useful to improve memory. Write a statement of declaration.




10 ways to quit smoking Tips On Stopping Smoking Posted By: Christopher Irwin Smoke Deter stop smoking spray consists of all natural ingredients that not only aid in the suppression of nicotine withdrawal symptoms, but also help to reduce cigarette cravings altogether. It will push the determination and the will power of the individual perhaps to the absolute limit. Given below is a compilation of some simple tips which will help you in your stop smoking escapade. Acupuncture has become a commonly used therapy which helps to quit smoking. The constant feeling of depression that one has to suffer from is wiped off; in short the person question becomes happier. Since there are so many programs out there, it is easy to find help to stop an addiction. Perhaps you have used pills, patches, e-cigarettes, and even tried to quit cold turkey to try to shake the habit. Laser therapy is also a well know quit smoking method. For more information on how to not get dry mouth, consult your doctor or dentist.


easy ways to stop smoking The Infamous Form Fda 483: How You Respond Can Make Or Break You Posted By: mukesh kumar Description: The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator’s view demonstrate an apparent violation of the applicable FDA regulations. The issuance of a 483 by the CSO at the conclusion of an inspection will be discussed with the establishment’s management and put them on notice that the nonconformities warrant correction and that a failure to do so may result in further action by the FDA, such as civil money penalties, seizure, injunction, and/or prosecution. Firm’s are well advised to take the warning seriously. Prior to an inspection, the CSO will review prior 483s issued to the establishment and the responses previously made by the firm concerning promised corrections. You will be held accountable for your prior response. What you promise and what you do, or don’t do, become critical factors in the FDA’s assessment of a firm’s capacity to operate in compliance with the FDA’s applicable requirements.
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.

sports nutrition manufacturer About The Safety Of Temporary Body Art Posted By: Anie Dee Since the invention of the ball point ink pen, children and adults alike have been writing various things on their hands, arms and legs. Notes to self, notes to others, patterns and designs as doodles while sitting idle in a class or waiting for a train. In the absence of paper, write on the hand. The inventors of ball point pen probably never realized they’d be used for temporary body art. The age-old question for those that use ink pens, sharpies, and other writing utensils for temporary body art is: will you die from blood poisoning by drawing on your skin with a pen or marker? My mother discouraged us using them when we were young as she believed it could be poisonous. Upon research, it turns out that it would take seven teaspoons of the ink directly ingested to be poisonous to a 90 pound child. Kids using ball point pens and other writing utensils are a decidedly safe way for kids to create a temporary tattoo. Companies have come out with gel pens and glitter pens over the years that are targeted towards kids.


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