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Showing posts from October, 2018

Conducting a Life Sciences documentation and Training Gap Analysis

Compliance Key - Life science webinars   Overview The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and operational requirements, and process descriptions all are foundational to both the training that must be conducted in a regulated facility and the actual compliance documents that must be created to meet all regulatory requirements. How a training and documentation professional undertakes an analysis to determine these requirements directly influences the quality of the training developed and fielded and the completeness and relevance of the compliance documentation prepared. Many regulated industries have a multitude of documents to meet their regulatory needs, training materials, SOPs, Work Instructions, Job Aids, and Performance Tests etc. all independently prepared complicating document control and impacting individual document effectiveness. One of the keys to both effec

ACH Government Payment Processing - Handling DNE's and Reclamations

Compliance Key - Bank webinars in United States   Overview Processing ACH payments from the Federal Government can be challenging! This session will outline details on when account holders are deceased and what your responsibilities are to the Federal Government if they are receiving benefit payments. The NACHA Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side by side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one. Why should you attend this webinar? In this 90-minute session you will hear all the details about how processing Federal Government payments differ from the NACHA Operating Rules. You will learn what the Green Book is and how this valuable on-line tool will help you with processing DNE's and Government Reclamations. Commercia

Are Your I-9's in Order? - ICE Promises a 5 Fold Increase in Enforcement Inspections

Compliance Key INC  - HR Webinar in United States Overview In the 2017 Fiscal Year ending 9/30/2017, Immigration and Customs Enforcement (ICE) conducted 1,360 I-9 audits during the entire year, In the 2018 Fiscal Year starting 10/1/2017, ICE has already conduced 2,282 through May 4, 2018. In addition, ICE has raised the fines for incorrect I-9 forms to $224 to $2,236 per incorrect I-9 form. The amount of the fine depends upon the percentage of incorrect I-9 forms. Recent I-9 Penalties issues by ICE: Buffalo Transportation Company - $109,000 for not completing Section 2 Asplundh - $95 Million Panda Express - $600,000 Florida Pizza Delivery Company, Pizzerias, LLC - $140,000 Don't let your company become a statistic. This webinar will concentrate on: The importance of understanding the requirements for completing I-9 Forms. The importance of the timeliness of completing I-9 forms. Determining best practices for Electronic Record keeping of I-9 Forms. Develo

HR Auditing: Critical Issues in 2019

Compliance Key INC  - HR Webinar in United States Overview Numerous external forces and factors have an impact on the purpose, scope, and demand for HR audits. First, in the global economy, human capital has become for many organizations the single most important determinant of competitiveness, productivity, sustainability, and profitability. Increasingly, the organization's human capital is the source of innovation and a driver of business success. Second, a confluence of economic, political, and social factors, including stockholder, plaintiffs, and third party initiatives, have resulted in increased statutory and regulatory requirements, the call for greater transparency, and increased internal and external audit activity. Third, governmental agencies have become more active - some would argue more aggressive - and have committed increasing resources to conducting assessments of employment policies and practices. Importantly, the EEOC, the OFCCP, U.S.

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Compliance Key INC  - FDA Compliance Training United States Overview Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations. Why should you attend this webinar? If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits. Areas Covered in the Session: Following

How to Prepare for an OCR HIPAA Breach Investigation

Compliance Key INC  -  Hipaa Webinar Overview There has been a trend towards higher settlements payments. There were 7 recent settlements over $1 million including $5.5 million, $3.9 million, and $2.75 million and 12 overall resolutions settlements. In 2017, there was continued HIPAA enforcement with a number of new settlements announced and the trend continues in 2018. Roger Severino, the Director of OCR, has said "enforcement is a key aspect of HIPAA" and organizations must embrace a "new posture of preventive security." If your organization experiences a HIPAA breach, OCR will be conducting an investigation and requesting compliance policies and procedures, risk assessment reports and training records. Find out how to prepare. The presenter for this webinar has worked with organizations under investigation by OCR. Attendees will leave the webinar clearly understanding of all the requirements that must be in place for HIPAA and how to demonst

Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements

Compliance Key INC  - FDA Compliance Training Overview Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain

HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

Compliance Key -  Hipaa Webinar Overview This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will speak on specific experiences from over 18 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information

How to Prepare for an OCR HIPAA Breach Investigation

Compliance Key - Online Hipaa Training for Employees Overview There has been a trend towards higher settlements payments. There were 7 recent settlements over $1 million including $5.5 million, $3.9 million, and $2.75 million and 12 overall resolutions settlements. In 2017, there was continued HIPAA enforcement with a number of new settlements announced and the trend continues in 2018. Roger Severino, the Director of OCR, has said "enforcement is a key aspect of HIPAA" and organizations must embrace a "new posture of preventive security." If your organization experiences a HIPAA breach, OCR will be conducting an investigation and requesting compliance policies and procedures, risk assessment reports and training records. Find out how to prepare. The presenter for this webinar has worked with organizations under investigation by OCR. Attendees will leave the webinar clearly understanding of all the requirements that must be in place for HIPAA