Overview: The topics will begin with an introduction into the basic healthcare compliance infrastructure necessary to establish a comprehensive and proactive compliance program. It will progress throughout the sessions to discuss current government auditing agencies and audits that are underway, as well as an in-depth discussion of government agencies responsible for protecting the Medicare Trust Fund from Fraud, Waste and Abuse. Our participa...

Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fun...

Course "Statistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to th...

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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...

Overview: The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003...

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and...

Overview: Upon completing this course participants should: Understand the limitations of the current exploration process Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts How to implement QA&QC procedures to guarantee the quality of the collected data Why should you attend? We will introduce you to an effective and affordable methodology that identifies prospective targets...

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be...

Course "Fundamental Laboratory Record Keeping and Compliance Issue" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Most of the focus on a laboratorys compliance to Good Laboratory Practice (GLP) or to the analogous ISO 17025 is on items such as the Standard Operating Procedures, training, quality assurance testing, and the statistical assessment of perf...

Course "HIPAA Privacy Security - Time to Get Serious" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I have conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Security...