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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

Enteric diseases are caused by micro-organisms such as parasites, bacteria, and viruses that cause intestinal illness. Enteric disease is caused by bacteria that are found inside of the small intestine. The term enteric describes the area where these bacteria attach to the lining of the small intestine, and it is generally thought that there are approximately five hundred different strains of this type of bacteria. An individual is not necessarily at risk for developing enteric disease, but those who have a family history of the disease are particularly at risk. Enteric diseases most often result from consuming contaminated water or food and some can spread from person to person. The emergence of COVID-19 (the novel coronavirus) is expected to propel the growth of the enteric disease testing market. For instance, according to the World Health Organization (WHO), worldwide, as of 5:01pm CET, 11 February 2021, there have been 106,991,090 confirmed cases of COVID-19, including 2,347,015 deaths. Increasing prevalence of enteric diseases worldwide and increasing launches and approvals of new products are expected to drive the enteric disease testing market growth. For instance, in October 2019, Mobidiag received CE-IVD marking for its Novodiag Stool Parasites test for the detection of intestinal parasites from stool samples. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/the-emergence-of-covid-19-to-augment.html