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...

Course "Validation and Part 11 Compliance of Computer Systems and Data” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitabilit...

Course "Requirements for Establishing an Effective Cleaning Validation Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunct...

Course "FDA Device Software Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with soft...

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Paul Hales, with a team of expert advisors and practical field testers, have created a method of making all HIPAA regulations accessible to the everyday person, explained in plain language with exact citations to each regulation for the benefit of the organizations' legal counsel who may not be experienced in HIP...

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and...

Overview: Think like and behave like an FDA investigator and recognize your greatest risks and vulnerabilities. Your authority to enter and inspect establishments is predicated upon specific obligations to the firm per FDA's documentation and we will review in detail. It is FDA's responsibility to conduct all inspections at reasonable times and within reasonable limits and in a reasonable manner. FDA needs to proceed with diplomacy, tact and p...

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...

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: In this seminar, we go through the known techniques of operational risk management, including of course the regulatory aspects, and point to a few shortcomings that appeared in several (possibly nameless) banks. We then go on to highlights on the pitfalls that await risk managers on the next Frontier, from which: what activities to outsource, setting up a risk appetite, developing a risk culture and a commensurate set of governance p...