The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the "healthcare software" dialogue....

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory perfo...

Course "A Risk Based Approach To IT Infrastructure Qualification & Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview:GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to pro...

Overview:This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains 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 and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The sec...

Course "Tougher Import Rules for FDA Imports in 2018" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Background: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import...

Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will spea...

Overview: Being in compliance with HIPAA in 2018 involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health In...

"Statistical Process Control & Process Capability" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed to othe...

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of do...

Overview: This two-day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains 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 and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The sec...