Compliance Training Webinars for Regulated Industries

This training program will provide a general overview of the Stark Law, the Anti-Kickback Statute and the Civil Monetary Penalties Law. It will also discuss requirements for compliance with key regulatory exceptions and safe harbors and best practices for implementing value-based physician compensation models.

This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.

This training program will discuss the manufacturer’s obligations mentioned in the EN 50581, 2012 guidance document. The topics in the guidance document will be explored from the perspective of a US manufacturer.

This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

This webinar training will discuss about the whistleblower claims and NO FEAR Act. The Instructor will discuss the types of whistleblower claims and new developments under the No FEAR Act. Participants will learn how to manage internal investigation and litigation issues.

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This training program will address OSHA’s initiative focusing on safety and health compliance for temporary workers. It will detail OSHA’s TWI initiative for temporary workers and review OSHA’s Bulletins 1-7.

This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.

In this session, the training instructor will provide a general Stark Law overview. He will also discuss best practices for auditing existing recruitment arrangements and for implementing new NPP support arrangements under the new 2016 Stark rules.

This training program will discuss the use of Employment Labor Law Audit (ELLA®) as a core competency, review the role HR auditing plays in helping your organization make critical business decisions, and describe how ELLA® can help reduce employment practices liability risk exposure.

This training program will detail the purpose of OFAC screening and OFAC risk assessment. It will define a politically exposed person (PEP). Further, the webinar will also offer best practices regarding the OFAC screening process and guide attendees on how to document the process of an OFAC case review.

This OSHA training program will discuss updated recordkeeping mandates set by OSHA and emphasize the importance of OSHA's recordkeeping regulations. The webinar will further detail why a failure to record a recordable illness or injury is a continuing violation and the D.C. circuit's decision in Volks II.

This webinar discusses how and why the demographics of country are changing and the business impact of an inclusive business environment. The instructor will explain the federal and state laws and policy that provide for equal employment opportunity and affirmative action in employment. Participants will learn how to develop a fair and equitable Affirmative Action Plan that can withstand scrutiny.

This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

This training program will review changes in the Foreign Trade Regulations, Export Administration Regulations, Office of Foreign Assets Controls, and the International Traffic in Arms Regulations. It will also offer an understanding of the basics of applying for an export license through the BIS.

This training program will detail developing a compliance manual and a code of ethics for the financial industry, with the intent of clarifying the requirements of the Advisers Act. The instructor will also guide attendees on testing the manual, effectively managing it, and keeping it constantly updated.

This course is designed to bring food industry leaders up to speed with the latest in related policy characteristics. The goal is to enable industry leaders to better understand the food policy landscape.

This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.