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Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Looking for reliable healthcare coding and consulting services? Our experienced team specializes in Medical coding services for healthcare organizations. With accuracy, efficiency, and compliance as our priorities, we can optimize your revenue and minimize audit risks.

Effective dental billing services result in increased patient satisfaction, decreased billing errors, and improved cash flow. Dental clinics can find the secret to financial success and a long-term by placing a high priority on revenue cycle management.

Acne commonly named vulgaris, a disorder of hair follicles of the face, back and chest or neck.acne also characterized by blackheads or whiteheads on oily skin (Pimples). Dermatologists find different treatments for improvement of this disorder by regulating oil-producing glands.

Vitamin b12 called cobalamine, important for vital functions in body, like maintenance. Deficiency cause malnutrition and digestion problems. Treatments including supplements, injections and vitamins regulatory measures.

Read how to measure weight and take healthy steps for reducing fats. Obesity is excess of your calories stored in adipose tissues as fats. BMI is used for calculating body mass in relation to stronger muscles.

Tremor is a rhythmic muscle movement involving automatic oscillations of the body parts, involuntary movements in legs, arms, head, face. Is started gradually often when we stressed and angry.

Personel care items like cosmetic including mascara foundations, body lotions and soaps, hair style products very vital value regarding health and science. Everybody used toxic chemicals in the form of cosmetics. How we take good and healthy steps for good and safe beauty.

A cancer registry is the cancer cases which are registered in a population or specific country. In whole world mortality rate due to cancer is 20%. In USA cancer is the second largest disease of causing death after heart disease. Recently in 2016 estimated that 595,690 people die from this disease according to cancer statistics of National Cancer Institute USA.

A brain is an organ often composed of Connective tissues and nerve cells. The brain contains three important parts including breathe controlling and muscles like moving muscles and sensing like emotions breathing, memory thinking and somewhat personality.

Brain Tumor risks including surgery facts, as well as diagnosis also types either the primary tumor or secondary tumor. Treatments like MRI CT scan helping you to decide better for your health.

Bleeding in semen caused by medical procedures, also known as hematospermia. Blood in semen caused by infections, tumors, and stones in organs as well as anatomical problems. The most common cause is a prostate biopsy.

How chemotherapy takes place? Depending on type of cancer and period of cancer, it stops cancer cells ability of damage and more to divide. Oftenly drugs are used and different for different person. This is systematic therapy also affect your entire body.

SLE or Lupus is an autoimmune disease that causes inflammation of the organs and swelling of the joints. It has vast effects on the renal, skeletal, gastrointestinal and blood systems. It affects mostly people of Chinese and African origin and presents in a capricious and unpredictable manner.

It explains the purpose of our blog which is to help improve the Health of the Masses. We dedicate ourselves to enhance the Medical knowledge available one line. We Strive to solve health-related issues compassionately and professionally.

Are you worried you are getting heavier day by day? Well, it might be because of those fries you are addicted to. Deep fried foods are rich in trans fats which are directly related to obesity and heart failure. Trans fats build up the blood vessels, hindering the smooth flow of blood through them.

Stroke is a cerebrovascular syndrome that involves the blockage and bursting of blood vessels in the brain. It shows a multifactorial pattern of inheritance. High cholesterol levels, high blood pressure, hypertension and obesity are the key causes of stroke besides inherited genes.

Motion sickness occurs as a result of a disagreement between the visual and vestibular systems of the body. It is characterized by symptoms of nausea, headache, and restlessness. Luckily, there are a number of home remedies you can try to cure travel sickness.

Tuberculosis or simply TB is a spreadable disease caused by Mycobacterium tuberculosis. This organism has a hard, waxy cell wall that makes it highly resistant to unfavorable environments and drugs. It evades the mucus lining of the windpipe and enters the lungs.

The goal of treating Tuberculosis is to protect the patient from possible disability and death. Another objective is to reduce the spread of Tuberculosis infection to others. TB may be a stubborn infection but with the right measures at the right time, it can be cured.