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Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

Overview: In this webinar, Hope will present the lessons she's learned over her career as a grant writer and editor in medical research. By identifying simple solutions to common problems, participants will learn tools to improve their ability create competitive grant applications and increase their academic and research productivity. To write compelling grant applications, this webinar will cover: How your choice of words will help you stay within page limits without compromising the science How to minimize abbreviations to improve readability and respect reviewer time constraints How to use Microsoft Word efficiently to improve page layout and readability How to manage references by enlisting online databases and reference management software How and when to stop developing the content to meet both grantor and institutional deadlines Why should you Attend: Many Grant Writing workshops do not teach writing per se. Though useful for beginning grant writers, most focus on understanding the application process and the various sections of a grant. For participants wanting to learn to actually write a grant, they are often left to figure out the technique for themselves. In addition, funding opportunity applications (FOAs) have changed quite rapidly in the past few years and require more focused writing in fewer pages. Competition has increased as budgets have shrunk, and knowing how to make the most out of both the time and the length of a grant project can prove challenging and extremely stressful. This webinar is for both new and experienced grant writers, either scientists and principal investigators or writers and other support staff. By using common resources (MS Word, EndNote, PubMed), the webinar content is designed to help grant-writing teams increase their efficiency in the writing process and also meet the requirements of the FOAs. Plus, plain language and good writing practices taught in this webinar will ensure straight-forward, content-rich, and well

Less than 2 months are left until the MIPS 2020 reporting deadline ends. Utilize this time to compile data strategically and target MIPS incentives. To score more in the MIPS Quality category, the best strategy is to focus more on measures that have a high-scoring margin.

QPP MIPS participation is a great way to stabilize finances in the shaking economic industry. Many professionals have already started to plan and strategize on how to get maximum score in the end. Given in this article is a complete guide on MIPS 2020 eligibility status. Going through it will help in setting up goals for participation.

The QPP MIPS participation starts from knowing the eligibility status. For MIPS 2020, clinicians can check eligibility via QPP Lookup Tool. Later on, CMS updates the eligibility status that if physicians can report data to them or not. However, the reporting requirements change each year due to changed policies.

QPP MIPS participation is a great way to stabilize finances in the shaking economic industry. Many professionals have already started to plan and strategize on how to get the maximum score in the end.

CMS extends the deadline for MIPS 2020 targeted review to help eligible clinicians check their data, score, payment adjustments, and apply for reweighting in case of any effect.

People with five or more hospital contacts with infections had an IQ score of 9.44 lower than the average.

Physicians! It's time to prepare for the MIPS 2019 reporting period. There's only a little time left. This time may be hectic and stressful, even for MIPS qualified registries. But don't worry, P3 Healthcare Solutions has come up with effective tips to target high MIPS scores. Let's be honest, MIPS QPP can be a daunting approach to earn incentives for those who are not careful.

Improvement activities (IA) - MIPS 2020 submission is incomplete without it - is easy to submit with the right MIPS consulting firm. Find out more about it.

Improvement activities (IA) - MIPS 2020 submission is incomplete without it - is easy to submit with the right MIPS consulting firm. Find out more about it.

Before implementing any EHR, EMR, or PM, clinicians must ask the right questions to see if the system adds value to their workflow or not. We have a list, read more.

The window for MIPS 2019 performance score review is closed now. Now, eligible physicians must focus on MIPS 2020 data submission and enjoy flexibilities amidst COVID to compensate for the lost revenue.

Recently CMS introduced modifications in the Stark Law to upgrade the referral system in order to promote better coordination and engagement while keeping cost under control.

Medical practices can amplify their MIPS performance via consulting and submitting data through MIPS Qualified registries.

Medical practices can amplify their MIPS 2020performance via consulting and submitting data through MIPS Qualified registries.

MIPS 2020 feedback is available for review by CMS. Clinicians can even ask for a targeted review in case of any error in the points or payment adjustments.