Many of us work in a regulated environment. We may work on the manufacturing floor of a pharmaceutical company or we may work in a clinical laboratory in a hospital. Many of us may work in a government laboratory or in an academic laboratory in a university. There is a common thread impacting all these settings which is known as cGXP. cGXP is a set of regulations which impact an organization to stay within compliance so as not to harm the public and result in closure of the institution. Within cGXP there are three categories which impact most workplaces and they are; cGMP, cGCP and cGLP. I will explain how these categories differ and the consequences that occur by not following these regulations. I am hoping that after this presentation, if you see something that is incorrect at your work place you will be able to cleverly point it out to your QA/compliance manager.
Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic and international audits(as appropriate) that ensure compliance with the FDA QSR, ISO, MDD, CMDR requirements, and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure. Continue reading Senior Quality Engineer – Healthcare company→
Over the last few years, there has been a significant shift throughout our health care system to move to a delivery and payment model known as value-based care (in replacement for Fee for service model). The value based is a solution to address rise in healthcare cost and focus on quality. This transition is very challenging, and the need for process improvements initiative is very imperative during the transitional period.
Presenter: Toyin Adegbonmire, MS, Blackbelt, is a Provider Reimbursement Manager at Healthfirst. She received her Bachelor’s degree in Health Administration from University of Maryland Baltimore County and Master’s in Technology Management with a concentration in Project Management degree from University of Maryland University College. She has been working in the healthcare industry for 10+ years with diverse experience in Health IT, Revenue recovery, Managed care organization and Skilled Nursing. Toyin is currently leading an improvement initiative to improve the claims auto adjudication process at Healthfirst.
Sepsis is associated with a high risk of mortality. The number of deaths in US due to sepsis has increased from 154,159 in 2000 to 207,427 in 2007. The main objective of this presentation is to demonstrate utilization of process improvement and system redesign methodologies for the purpose of improving broad spectrum antibiotics administration within 1 hour of severe sepsis/septic shock recognition, and studying its effect on mortality. Continue reading June Section Meeting: Healthcare Process Improvement – Early Sepsis Identification→
This month we will discuss how to align financial incentives, focus on important quality measures and redesign care in order to improve the health of populations. He will cover the basics and current state of the industry in its move to leverage value based payment systems; the evolution and challenges of quality metrics from strict clinical procedure outcomes to longer term care and ultimately health outcomes; and how care systems are being resigned to better promote population health.
Andrew Rein is a mission-driven senior executive with 20+ years of experience acquired in executive positions in the nation’s leading health care and public health organizations, and a proven ability to lead health system transformation and reform, population health, and organizational innovation. Andrew maximizes value by uniquely weaving strong performance and financial management, strategy development and implementation, policy priorities, and deep analytics. Continue reading March Section Meeting – Transition to Value-based Healthcare→