Overview: Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device! The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,...

Increased Revenue & Profit For Your Practice! Better Service & Outcomes For Your Patients From Your Existing Patient Base! This seminar will provide you with the following critical information and materials: How to develop Profits $5,000-$20,000+ Per Month, Per Doctor though Durable Medical Equipment (with but a few patients a week or day) How to Become Immediate Positive Cash-Flow How to provide a "Convenient One-Stop Medical Shopping...

Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule. Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more. I will uncover myths versus reality as it relates to this very enigmatic law based...

Connected Health Summit: Engaging Consumers spotlights health technologies as part of the Internet of Things (IoT) phenomenon and the transformational impact of these connected solutions on the U.S. healthcare system. This focus provides strategic insights into consumer engagement, care accountability, service innovations, and platform design to determine successful approaches in the deployment of connected healthcare products and services. Fo...

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 "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 "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 "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...