Course "The A to Z's of HIPAA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant an...

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...

Course "Clinical Research for Cardiovascular Pharmaceuticals: Ensuring Compliance of Traditional and New Cardiovascular Medications" has been pre-approved by RAPS as eligible for up to12 credits towards a participant's RAC recertification upon full completion. Overview: Understanding basic clinical research requires excellent people and project management skills, and very good scientific writing and organization skills. Also paramount is gathe...

Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: Specific areas covered will be: HIPAA now has teeth and funding - a background Be proactive NOT reactive - importance of this based on real life experiences What is involved in a HIPAA audit - from real life events Patients su...

Overview: Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integr...

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...

The Center for Digital Education is hosting a Market Briefing event in San Diego and we hope you can join us. IT leaders from some of the largest districts in San Diego will be on hand for a special briefing on their technology plans, priorities and focus for the coming years. The participants will be briefing the audience on district plans in a variety of topic areas, including computing infrastructure, mobile devices, digital content and cur...

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...