In this prescription drug pricing webinar attendees will the key components of the trump administration on drug pricing plan, elements of the white house drug pricing blueprint and the federal policy outlook for U.S. drug pricing in 2019 and beyond.
This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.
This Utilization and Denial Management webinar will assist the case management department leader and RN case manager in understanding the role of utilization management in a busy case management department. Determining the optimal model for ensuring the best approach to making sure that all cases are billed appropriately and timely is essential. This webinar will discuss two models, as well as the new concept of artificial intelligence that can be utilized as an adjunct to the medical necessity process.
In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment.
It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
In this food safety webinar attendees will learn how to set up a robust allergen control plan with latest approaches for cleaning, validation, monitoring and preventative controls required under FSMA (Food Safety Modernization Act). Also attendees will learn insights for testing, laboratory review and cleaning practices to improve or review their allergen management program.
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.
This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.
The FDA sites hundreds of companies each year for not adequately performing and documenting out of specification results. This course is designed to provide instruction on how to thoroughly document and investigate out of specification results using approaches which have been recommended by regulatory authorities.
Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.
Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them. This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.
Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.
New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
This webinar is focused on the Quality Management System' oversight of manufacturing and its documentation. What is required of a compliant system according to ISO 9001, 21 CFR 820 / ISO 13485, and 21 CFR 210 and 211 ..
This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.
This webinar will provide an in-depth review of enforcement actions taken by the HHS OIG over the previous two months. We will also briefly review the Anti-Kickback Statute (“AKS”), discuss any new safe harbors, and OIG Advisory Opinions that have been issued.
