Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
This course is organized into three sections: The life cycle of a claim, coding systems, and reimbursement.
Life cycle of a claim
Many people understand a portion of the claim adjudication process, but they may not have a complete understanding of all steps necessary to generate and adjudicate claims. We walk through the entire life cycle of a medical claim, from patient registration through provision of services, from claim generation to adjudication, from payment to posting. This is useful for anyone new to the healthcare industry or for persons who want a more complete understanding of the entire claim life cycle.
GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance.
The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.
Employers are getting it - sort of. Most believe in the concept of keeping their employees healthy because it just makes sense.
Not only does paying attention to this make a difference in the lives of the people who are the most valuable asset to a company, but there are also many benefits to the bottom line - lowered health claims, improved energy and morale, lowered sickness, and improved productivity.
Typical wellness programs may include conducting an annual health fair, inviting a speaker to do the odd lunch n' learn, or even providing gym or fitness subsidies. These initiatives are certainly good starting points, but are they worked into the overall objectives of the organization? Will companies really get the biggest bang for their buck? A one-size fits all program/lunch n' learn/health fair will not have the same effect or return.
This webinar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.
This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. This includes how to properly validate an FDA-regulated computer system in order to ensure security and data integrity objectives are met.
Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Why you should attend
It is not possible to present a complete treatment of project management in the span of 6-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
Managers who want to increase their competitive advantage by anticipating their customers' priorities, needs and expectations
Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs' flexibility and responsiveness
Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department's value to the organization
Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!
An analytical method is a process. The FDA process validation guidance
applies to test methods, like all other processes in the pharmaceutical
industry. Therefore, the laboratory or laboratories must demonstrate that a
test method performs as intended through the method lifecycle.
Why should you Attend:
Observations that test methods are inadequate or the firm does not have
appropriate data that demonstrates the method performs as intended rank
high on the list of observations in the laboratory.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:
Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game.
Participants will learn about the following:
The claim flow process from registration through adjudication and payment
How physicians and hospitals set and manage charges.
The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolving for most efficient strategic planning.
Why should you Attend:
This webinar will give you a snap shot of what is current, what is coming and what this means to anyone who is currently developing Drugs and other Health Products for the Canadian market. The focus will be on drugs, biologics and medical devices.
Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions and corrective actions on duly manner.
This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities.
Case management, as a member of the revenue cycle team, plays a strategic role in the implementation of strategies aimed at reducing and/or preventing third party payer denials. Reducing and preventing denials requires proactive and hard-wired processes that engage the entire interdisciplinary care team. The causes of denials are complex and therefore require complex solutions. This program will review the causes of denials and key strategies for reducing and preventing them. Solutions will include key members of the interdisciplinary care team including physicians, physician advisors, case management leaders and case managers. Strategies for analyzing your denial rate will also be included. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Case-Management-s-Role-in-Managing-Third-Party-Payer-Denials-504198/DECEMBER-2017-ES-TRAININGREGISTRY
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.
The medical device professional will often take the lead role in overseeing all aspects of regulatory & quality compliance, including CMC aspects, particularly when the "primary mode of action" relates to the device component.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done.
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites.
This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.