A Standard Operating Procedure (SOP) is defined as a written instruction that elaborates how a task should be performed including when, by whom and where. SOP plays a crucial role in ensuring consistent quality in the pharmaceutical products and best practices in the pharmaceutical unit. It also plays a major role in risk mitigation and therefore proper implementation of SOP is essential. Creating and maintaining SOPs could be a complex task. And, most of the SOPs are quite complicated to read and follow on a daily basis. They mostly contain too much of details and instructions which often increases the risk of errors. Writing effective SOPs for pharmaceuticals is all about documenting the right amount of details that help in carrying out a quality procedure without causing confusions. Many companies write SOPs that emphasize “how” but do not essentially cover “why.”
FDA audit could be nerve-racking for medical device manufacturers if they are not well prepared. Over the last few years, medical device firms have encountered a significantly heightened number of inspections that resulted in increase in the number of citations. Although difficult, FDA audit is an important aspect of medical device industry. However, especially for startups, the first audit could be quite difficult to handle as the checklist of FDA could scare away the potential investors or customers, hindering the organization’s goal and efforts. Moreover, FDA sometimes announces their audit beforehand but the regulators may also turn up any time for inspection, without any notice. This implies, being a medical device manufacturer, you always need to be prepared for going through an FDA audit.
Getting accurate results in clinical trials depends on several factors and an important one among those is site selection. For executing a clinical trial successfully, it’s important to identify and work in an effective site that ensures that the patients are safe and the procedures are effective. While selecting a site for clinical trials, several things need to be considered like availability of suitable patients, experienced staff, track record with previous trials, diagnostic and therapeutic equipment available, geographic location etc. The sponsor needs to perform due diligence to make sure that the site meets all the requirements for the successful execution of a clinical trial. Budget of the trialalso needs careful consideration in site selection for clinical trials. Continue reading “Site Selection for Clinical Trials – Best Practices”
Continuing education programs refer to learning activities aimed at educating professionals and helping them advance their skills and knowledge regarding their field of work. The programs include webinars, seminars, formal lectures and many more. These are optional for certain professionals whereas for some these are required for maintaining certification or licensure. A continuing education credit (CEC) or continuing education unit (CEU) is a measure used in continuing education programs. A CEU equals to 10 hours of participation in an accredited program. Training Doyens offers CEU approved webinars for various industries. By attending the webinars you can not only enhance your knowledge and skills but can also earn CEUs to establish yourself as a competent and expert professional. Training Doyens features webinars approved by SHRM, HRCI and IRS.
There are a number of good reasons why professionals from different industries are becoming more inclined towards Professional Certifications. Such certifications not only validate the skills and expertise of an individual but also help industries in defining and maintaining specific standards. Earning a professional certification takes you much ahead of competition and provides more credibility to you as a professional. Also, these programs help you in staying updated and informed about what’s going on in your industry. Many organizations offer professional certification programs and Training Doyens is one of them, featuring top notch certifications.
Membership Packages & Corporate Training in today’s era internet plays a very important role in, practically, every industry. Businesses are highly dependent upon internet based tools and services for operations, strategy formulation, and what not. Moreover, internet has also made professional learning more and more convenient and one such example is webinars.Webinars help you learn about the things relevant to your profession from a convenient location. All you need is a device with internet connectivity and you can enhance your professional capabilities to unimaginable extents. Training Doyens organizes insightful webinars related to multiple industries including, but on limited to, healthcare, banking, human resources and cross industry functions. Experts hailing from different industries present interactive sessions, where you can also discusses your thoughts and ideas. However, the ultimate aim is to enrich you with acumen and skills for shaping up effective business plans and strategies.
The Drug Enforcement Administration (DEA) mandates regulations governing the drug disposal of controlled drugs by the ultimate user (patient). The regulations do not prohibit the patient or family member from disposing of medications in their home. However, they expand the options for this disposal to include and encourage the use of authorized collectors which will include pharmacies, hospitals, clinics within pharmacies, certain manufacturers, distributors, and law enforcement agencies. All of these collection options are voluntary and the disposal regulation does not require the patient to utilize any of these methods for disposal of controlled substances.The agency has also revised the regulation recently and any method of drug disposal that was valid prior to the new regulation continues to be valid. Thus thenew regulation does not prohibit the patient (or family member within the household) from using current existing lawful methods for drug disposal.
Developing cost effective new drugs and therapies is a major challenge for life science industry. Drug development involves a number of phases among which the clinical trial management phase is the most complex one. It needs planning, execution and monitoring of clinical trials to obtain reliable study data for regulatory submissions. However, in the clinical trial management, one of the major costs owes to the clinical monitoring. Studies have revealed that conducting frequent monitoring visits to investigational sites and 100% source data verification (SDV)through traditional ways don’t always lead to high data quality. This calls for a smarter and better approach for more efficient study data monitoring. A number of monitoring approaches have evolved these days but the centralized monitoring has been proved to be the most effective approach for improving patient safety and data quality in a cost effective manner. Many regulatory bodies, including FDA, encourage the use of centralized monitoring.
HIPAA violations breaches could cost your organization thousands of dollars, in addition to damaging your reputation and relationship with your patients. Penalties for not complying with HIPAA rules are divided into two categories: Reasonable Cause and Willful Neglect. Fine for a HIPAA breach owing to reasonable cause ranges between $100 and $50,000 per incident and doesn’t include any jail time. However, in case of willful neglect, the fine ranges from$10,000 to $50,000 for each incident and could also lead to criminal charges. Even a small HIPAA violation on the part of a single employee could jeopardize the reputation of the entire organization. Continue reading “Tips to Avoid Common HIPAA Violations”
With the implementation of new technologies, adoption of electronic health record technology and association with health information exchanges, more healthcare organizations are exposing themselves to HIPAA data breaches and other online threats. In this scenario Protected Health Information (PHI), in addition to being available to the concerned people, is also becoming more and more accessible to hackers and unauthorized third parties. This means covered entities and business associates need to stay updated about the advancing technologies to maintain PHI security. Understanding the basics and underlying reasons for HIPAA data breach is the first step in creating comprehensive data security plans which the healthcare organizations can apply to their daily operations. Continue reading “Rules And Regulations Surrounding HIPAA Data Breach”