Group items tagged

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

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addition to

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addit

Over-the-counter drugs (also known as non-prescription drugs) are drugs that one can buy without a prescription. These drugs are widely used to treat conditions that do not require direct consultation. Moreover, over-the-counter drugs are effective and safe when a consumer follows the instructions on the label or is provided by a doctor. The Food and Drug Administration in the United States considers when a specific drug is safe and effective enough to be sold over-the-counter. Over-the-counter drugs are widely used to treat symptoms of cold and flu worldwide. Several pharmaceutical manufacturers are focused on converting Rx (prescription drugs) to OTC (over-the-counter drugs) to meet the increasing demand. In the first half of 2019, Tachipirina was the best-selling non-prescription medication (over-the-counter drug) in Italian pharmacies. Rx to OTC switch is the transfer of proven prescription drugs to nonprescription. In February 2020, the FDA converted three prescription drugs to over-the-counter drugs, increasing access to the medicines. Moreover, many people worldwide prefer OTC drugs to treat minor illnesses before seeking professional care. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/over-counter-drugs-are-safe-and.html

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

HIPAA Privacy Myths: HIPAA, the most comprehensive and as of now, the only truly Pan-American federal statute on health information, is unfortunately, still a target of misconceptions and myths. In particular, the Privacy Rule, which is the cornerstone of HIPAA's rule on confidentiality of patient information, offers room for many misconceptions. A few common HIPAA Privacy Myths: HIPAA Privacy Myths regarding communication between the patient and physician A common HIPAA Privacy Myth relates to the communication of mails between the patient and the physician. It is a common misconception that since the Privacy Rule is about ensuring the patient's privacy; it disallows email communication between the doctor and the patient. HIPAA Privacy Rule does allow this form of communication, so that the requisite safeguards are built into the communication aimed at ensuring the confidentiality and integrity of the mails. Transmission of the patient's protected health information Another of the common HIPAA Privacy Myths pertains to the transmission of patient information from one healthcare facility to another. Fact is, no permission is required for Covered Entities to disclose patient information from one clinic to another. The Covered Entity can also share Protected Health Information about the patient for legitimate purposes without the patient's consent or knowledge. Cumbersome and expensive HIPAA Privacy Rule regulations Many people tend to believe that the HIPAA Privacy Rule is a tangled web of regulations that are so complex and painstaking in terms of the administrative detail that implementation of the HIPAA Privacy Rule on a national scale is going to burn a hole in the national exchequer. This is completely untrue. On the contrary, over the years, implementation of the HIPAA Privacy Rule has been bringing down the administrative costs quite significantly, resulting in saving of a few billion dollars in the long run on administrative tasks like transactions

Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp

Bariatric Wheelchair is often referred to as a Heavy Duty Wheelchair or Extra Wide Wheelchair with extra weight capacity, reinforced cross braces, and various other design features to ensure that there is reliable durability to handle the extra support. Whether it is additional weight capacity requirements, or simply a wider seat pan or seat width, a wide range of chairs available in the Bariatric category, there are several models and seat widths to choose from in the Reclining Wheelchair or otherwise known as High Back Wheelchair Category. Bariatric Wheelchair is a supportive and comfortable device that provides users with a safe way to experience more independence. The rugged frame made from high-strength aluminum is lightweight yet handles up to maximum weigh so that bariatric patients can have greatly expanded mobility. A wide seat, wider-than-usual casters and tires and double crossbraces provide a reliable and stable foundation that keeps users safe and satisfied. The nylon upholstery is highly breathable, minimizing moisture even during extended periods of use. The Bariatric Wheelchair flip-back, padded armrests and the anti-slip footplates are both adjustable, enabling to get a precisely customized fit. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Commodes are used with a plastic commode pan that must be emptied at regular intervals. The commode pan is removed either by lifting it out from the top or by sliding it out from underneath. These commodes are only designed to transport the user a short distance, e.g across a bathroom, and are not an alternative to a wheelchair. People difficulty standing from chairs, toilets etc then it is important that the commode use has armrests and has a suitable seat height. Ideally, users shou