Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures a...

Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification...

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 da...

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,...

Earn Continuing Medical Education (CME) credits at this event! Recognizing that the care and well being of our warfighters does not stop when they return home, IDGA are proud to welcome a diverse group of subject matters being addressed by both DoD and VA speakers. As our troops return from theater, healthcare professionals need to identify many of their symptoms, both physical and behavioral. Many of the psychological wounds, such as TBI and...

This conference is the annual meeting for those involved in facilities planning and construction, academic program planning, finance and capital planning, space planning and management, administration, and operation of academic medical & health science centers (i.e. medical schools, hospitals & clinics, research centers, health professions programs, and health science programs). New integrated plans (programs, facilities, and finance)...

San Diego's climate and region increases its risk for wildfires, earthquakes and flooding, and requires continuous collaboration and information sharing across all levels of response and emergency management. Its ranking as a UASI area magnifies the need for homeland security officers to integrate preparedness activities to ensure the security of our borders. Join your peers across all areas of homeland security and emergency preparedness to s...

Target Audience This conference is designed to meet the needs of direct health care providers, managers, administrators, risk managers, educators, industrial hygienists/safety professionals, and researchers of any discipline who are interested in advancing safety for patients and caregivers. To meet the needs of a diverse audience, focused tracks have been established for: Track A: Direct Patient Care Providers/Peer Leaders responsible for pat...