Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own man...

Overview: There are mandatory, elective, and optional topics. These topics are outlined in the specific industry procedures. Mandatory topics are required and must be conducted for the minimum amount of time indicated. These topics are determined by OSHA and include: OSHA Orientation Work in Confined & Enclosed Spaces Walking/Working Surfaces; ladders, scaffolds, fall protection, etc. Personal Protective Equipment, all types Basic Electric...

Course "US Medical Device Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Break Overnight Clinical Trials IDE Other Export for trials Common problems in trial design and management Post marketing QSR CAPA Reporting Inspections Export for foreign markets Pop quiz Give quiz Discuss questions and answers Why should you attend? Have you had the e...

Empowering Patients, Advancing Care The research is clear: Patients who take an active role in their care tend to have healthier outcomes. But with the rapid evolution of the healthcare landscape, and the constant emergence of new technologies, the path toeffective engagement can feel murky at best. How do you inspire patients—and your entire organization—to adopt a new paradigm of patient-driven care? Which solutions are here to s...

Overview: The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into har...

Overview: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics,...

Overview: In order to qualify as a food safety transportation leader, you will need to understand what and how to implement FDA FSMA rules on the sanitary transportation of human and animal foods. This training will include detailed information on these rules and will include food safety topics generally established by FSMA to assist in your company's approach to transportation tools, load, unload, driver and transportation food safety practic...

HealthTech, formerly HealthSec, is now in its second year with a broader scope designed to encourage the development of new technologies that generally improve the quality and safety of healthcare as well as the access to it. By bringing together researchers, practitioners, and industrial partners, HealthTech aims to provide a forum for cross-disciplinary interactions among the technology, medicine, and policy communities. The day-long summit...

The Aerospace Medical Association’s 2014 Annual Scientific Meeting will be held in San Diego, CA. This year’s theme is “Exploring the Frontiers of Aerospace Medicine Human Performance.” Based upon the responses to a survey provided at the end of the 84th Annual Scientific Meeting in Chicago, IL, our members indicated a need for more information in six major categories: 1) Human Performance/Human Factors, 2) Aerospace Me...

Physical therapy and rehabilitation initiatives are some of the most pertinent topics for military medical professionals to explore. Given advancements in technology, armor, and medicine, less than 5% of soldiers die from wounds sustained in combat. This is an extraordinarily encouraging statistic, but it also means that the military healthcare system must care for an unprecedented number of wounded warriors. Operation Enduring Freedom, Operat...