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How Risk Management in ISO 9001:2015 May Change Quality Management In a sense, quality management has always been about ensuring the output of a group meets a consistent, acceptable level. But this new emphasis on higher level risk impact may put quality management representatives (including organizational quality personnel, consultants and auditors) in the position of managing higher level business risks.  The Gap Analysis Toolkit will: Provide the tools and checklist you need to conduct your Gap Analysis Provide a detailed checklist to use to compare your current systems to the requirements of ISO 9001:2015. Give you the information you need to determine resources and a timeline for your project. The Gap Analysis Checklist features: A detailed 38 page checklist covering every section that requires modification (between ISO 9001:2008 and ISO 9001:2015). In Microsoft Word format for easy editing. Space for notes

Millions of people who take statins to lower cholesterol may not get maximum protection from flu vaccines, two new studies suggest. Both studies looked at the effectiveness of flu vaccines in people who were or were not using statins. Taken together, the results connect statins to a dampened immune response to flu vaccines and greater odds of respiratory infections during flu season. Clik Here

Parkinson's Disease 1. Smoking lowers risk of Parkinson's disease Numerous studies have identified the mysterious inverse relationship between smoking and Parkinson's disease. Long-term smokers are somehow protected against Parkinson's, and it's not because smokers die of other things earlier. The most recent, well-conducted study was published in a March 2010 issue of the journal Neurology. Far from determining a cause for the protective effect, these researchers found that the number of years spent smoking, more so than the number of cigarettes smoked daily, mattered more for a stronger protective effect. Harvard researchers were among the first to provide convincing evidence that smokers were less likely to develop Parkinson's. In a study published in Neurology in March 2007, these researchers found the protective effect wanes after smokers quit. And they concluded, in their special scientific way, that they didn't have a clue as t

Definition of Validation  according to (FDA Guidelines 1987): "Establishing the documented evidence which provides a high degree of assurance that a specific process will consistently produce a product of predetermined specifications and quality attributes.” Definition of Validation according to according to (FDA Guidelines, 2011): “Process validation is defined as the collection & evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that process is capable of consistently delivering quality product.” Definition of Validation according to according to (EU GMP 1997): “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results.” Benefits of Validation: Validation can reduce costs by reducing, Rejects Reworks Reliance on In-process con

It's the golden question in financial circles: How much does one need to save for retirement? Some people say even $1 million isn't enough. I think that's ridiculous; those people have serious  spending issues  .  But the average American over 65 has about $175,000 in savings, according to Vanguard, and I think that's too little, as it provides just $7,000 a year for living expenses.  Read more

Pharmaceuticals Manufacturing Technology Writer: Shayne Cox Gad A Johnley & Sons Inc. Publication Download Full Book (pdf): Click Here

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According to the Mayoclinic: Asthma is a condition in which your airways narrow and swell and produce extra mucus . This can make breathing difficult and trigger coughing, wheezing and shortness of breath. Classification of anti-asthmatic drugs:    1.  Beta2-adrenoceptor agonists         Short acting &  Long acting                 2.  Corticosteroids                 3.  Antimuscarinic bronchodilators                 4.  Theophylline Beta2-adrenoceptor agonists:         A.  Short acting: Beta2-adrenoceptor agonists relieve asthma by relaxing the bronchial smooth muscle to produce dilatation of the bronchi . They are available in form of pills, liquids, inhalants and sprays. Example:  Salbutamol and Terbutaline.       B.  Long acting: Long-acting beta2-adrenoceptor agonists exert a prolonged effect on reversing airway obstruction. These medicines should be used for the shortest duration of time required to achie

Classification of antihypertensive drugs: According to mode of action antihypertensive drugs are classify as  given below : Centrally acting antihypertensive drugs. Peripheral nervous system acting antihypertensive drugs. Calcium Channel Blockers (CCB). Diuretics. Angiotensin Converting Enzyme (ACE) Inhibitors. Angiotensin-II Antagonists. Direct vasodilation. Centrally acting Antihypertensive drugs Ex: Clonidine, Methyldopa. Mechanism of Action of methyldopa: Methyldopa  a prodrug  that exhibit its antihypertensive action via an active metabolite ( α -methynorepinephrine). Act on central α 2A receptors to decrease sympathetic outflow – fall in BP. Peripheral nervous system acting antihypertensive drugs        1.  ß-adrenergic blockers: a.       Non selective: Propranolol  (others: nadolol, timolol, pindolol, labetolol) b.       Cardioselective: Metoprolol  (others: atenolol , esmolol, betaxolol)     M

Antibiotics Mechanism of Action  1.    Cell Wall Synthesis: Penicillins: Mechanism of Action: Interferes with bacterial cell wall synthesis. Cephalosporines: Mechanism of Action: Disrupts the synthesis of the peptidoglycan layer of bacterial cell walls . Sub-Categories: Ø   first generation Ex. Cephalothin, Cephazolin. Ø   second generation Ex. Cefaclor, Cefuroxime. Ø   third generation Ex. Cefixime, Ceftriaxone. Ø   fourth generation Ex. Cefepime. Ø   Fifth generation Ex. Ceftobiprole. Vancomycin Mechanism of Action:   Bactericidal, an inhibitor of cell wall synthesis .        2.    Nucleic Acid Synthesis: Fluoroquinolones Mechanism of Action: Blocks DNA replication via inhibition of DNA gyrase. Subclassification and tested examples: Ø   Ciprofloxacin Ø   Levofloxacin           3. 30s Sub-Unit Ribosome Inhibition: Aminoglycosids Mechanism of Action: Ø   Bactericidal.