Skip to main content

Posts

Showing posts from October, 2017

Assurances: What are they; why and when do I need them?

Compliance Key INC  -  Medical Device Training                                          Sarah Fowler-Dixon Sarah Fowler-Dixon, PhD has been working with the Washington University since May 2001. During that time, Dr. Fowler-Dixon has been a member of one or more of the IRB reviewing committees, written and/or revised numerous guidelines and submittal forms, and served on a data safety monitoring board, given hundreds of presentations on the ethics and regulations of human subjects locally and nationally.  Webinar Id:  LSHCAS001  10:00am PT | 01:00pm ET  12/08/2017  Duration 60min mins  Overview The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agr

Oversight & Signatures

Compliance Key INC - Medical Device Training                                            Jennifer L. Searfoss Jennifer is the Managing Owner and Chief Solutions Strategist of SCG Health, LLC since 2011. SCG Health is a boutique value improvement organization focused on creating value in healthcare through workflow optimization, revenue cycle management and strategic planning in this post-health reform industry.   Webinar Id:  LSHCOJ001   12:30pm PT | 03:30pm ET  12/07/2017  Duration 60min mins  Overview CMS and other payers are cracking down on rules for signatures used on claims and orders - missing signatures and improper supervision of orders is an easy way for payers to pull back otherwise legitimate payments from your practice. Get the low-down on signature rules (including signature stamps) and how to properly order services. Why should you attend this webinar? To avoid penalties and missing out on payment Areas Covered in the Session: Double checking

Paying for Referrals: Risky Behavior

Compliance Key INC  -  Medical Device training                                        William Mack Copeland William Mack Copeland, MS, JD, PhD, LFACHE is Keynote Speaker at Compliance Key INC. He practices health care law in Cincinnati at the firm of Copeland Law, LLC, where he is president and CEO. He is also president of Executive & Managerial Development Group, a consulting entity providing compliance and other fraud and abuse related services. A graduate of Northern Kentucky University Salmon P. Chase College of Law, Bill is a frequent author and speaker on health law topics.   Webinar Id:  LSHCWLP001  10:00 AM PT | 01:00 PM ET  12/07/2017  Duration 60 mins  Overview The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute?s available safe harbors. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, sh

HIPAA Privacy and Security - Time to get Serious: Understanding by video

Compliance Key INC - HIPAA Compliance Training Seminar   Check out our Video for HIPAA Privacy and Security - Time to get Serious:  Seminar Id:  IJ2017S1  9:00 AM PT | 06:00 PM ET  10/27/2017  Duration 1 Day Brian L Tuttle will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. Compliance Key INC 717-208-8666 http://www.compliancekey.us/

CMO Supplier Quality Agreements :- How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturer

Compliance Key INC  -  Compliance Online Training                                             Roger Cowan Roger Cowan is the Keynote Spaker at Compliance Key Inc. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing.  Webinar Id:  LSHCRC007  10:00 AM PT | 01:00 PM ET  12/07/2017  Duration 60 mins Overview A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug.  Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing Arrangements for

Form I-9 Compliance For Small Business

Compliance Key INC  -  Compliance Online Training                                  Matthew W. Burr Matthew Burr has over ten years of experience working in the human resources field, starting his career as an Industrial Relations Intern at Kennedy Valve Manufacturing to most recently founding and managing a human resource consulting company; Burr Consulting, LLC. He specializes in labor and employment law, conflict resolution, performance management, employee relations and work with labor unions.   Webinar Id:  CICMF001  12:30 PM PT | 03:30 PM ET  11/28/2017  Duration 60 mins  Overview This training will focus on the importance of I-9 compliance for small businesses. The training will introduce the I-9 forms, importance of filling out the forms correctly, retention process and proactive I-9 audits. We will also discuss common mistakes and how to correct. Why should you attend this webinar? Form I-9 Legal Information Importance of Mistake Proof Forms

Pharmaceutical Compressed Air :- Quality GMP Standards and Requirements

Compliance Key INC  -  Medical Device Training                                             Roger Cowan Roger Cowan is the Keynote Spaker at Compliance Key Inc. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing.  Webinar Id:  LSHCRC005  10:00 AM PT | 01:00 PM ET  11/17/2017  Duration 60 mins  Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.  Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system. Why should you at

Ethics in the Financial Services Industry

Compliance Key INC - Financial Services                                   Lisa M. Marsden Lisa M. Marsden, IACCP, is Keynote speaker at Compliance Key, Inc . She is the president and founder of Coulter Strategic Services. Coulter Strategic Services provides financial advisors and consulting firms with compliance and project management services. Prior to that, Ms. Marsden was the chief operating officer/chief compliance officer of Financial Trust Asset Management, Boca Raton, Florida.  Webinar Id:  CIFNLM007  12:30 PM PT | 03:30 PM ET  11/20/2017  Duration 60 mins  Overview The Application and practice of Ethical behavior is not just about complying with rules and regulations but about doing the right thing. This session will discuss case studies and how to apply the best practical ethical behaviors and how to incorporate the ethical behavior into your firm's overall business culture. Why should you attend this webinar? To gain an advantage in the ever

Understanding the Decision Points of Self-Disclosures and Repayment Obligations

Compliance Key INC - Healthcare Compliance Webinars                                                           Jay Anstine Jay Anstine Keynote Speaker at Compliance key Inc . He is the President of Bluebird Healthlaw Partners, LLC. As a healthcare lawyer specializing in regulatory compliance, Mr. Anstine consults to physicians, senior management, and boards of directors on compliance programs and regulatory issues impacting operations. Mr. Anstine's professional background includes working on the provider and the payer side of the market, for large for-profit and non-profit health systems, and small physician-owned entities.  Webinar Id:  LSHCUJA021  10:00 AM PT | 01:00 PM ET  12/06/2017  Duration 60 mins  Overview Historically, providers and suppliers enrolled in federal government healthcare programs have reconciled and returned overpayments through various post-payment audits. Additionally, these same entities have voluntarily returned self-identified overpay