Compliance Training (Corporate/Workplace)

Overview This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements. Why should you Attend Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success. This webinar will help you understand the various interpretations. We will discuss concepts for creating a culture of quality and management excellence with your company.

This 60 minute Get Organized with Outlook session will encourage and enlightened Outlook users on how to use Microsoft Outlook to more confidently and efficiently organize their information and commitments. Participants will learn smarter tips, tricks and systems to better manage their tasks, follow-ups, contacts, notes and calendar items. Don't worry, this not a boring computer class (you'll have fun!) and you get my no tech-talk guarantee!

Most large losses have been due, at least partly, to the occurrence of operational risks. Whilst financial institutions like to show that they know about this type of risks, the profession has been slow to learn from other older industries for which risk management is a critical factor. The banking world has been subject to avoid large debacles due to e.g. rogue trading and unharnessed macroeconomic turbulences. It is now critical for banks to set up robust but flexible comprehensive frameworks to handle these risks at reasonable costs and to the satisfaction of stakeholders, without compromising any legitimate drive to go forward and advance in sophistication.

Many employers think that if they offer severance pay conditioned on certain restrictions that they have eliminated all legal risks, and assume everything is fine-until it's not. For example, do you condition severance pay on promises not to sue and other post-termination restrictions? Did you know that you might be contractually obligated to provide severance pay even if you do not have a written agreement? Did you know that your severance agreement may not protect you as much as you think? Or that it may not be enforceable? Is your severance arrangement subject to ERISA laws? Attend this webinar to learn more.

The Americans with Disabilities Act (ADA) was signed into law by George H.W. Bush in July 1990. The Act is a civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the general public. The purpose of the law is to ensure that people with disabilities have the same rights and opportunities similar to those provided to individuals on the basis of race, color, sex, national origin, age, and religion. Disability accommodation is an important and visible aspect of ethical business practices. Compliance with the Americans with Disabilities Act will ensure your organization is operating in an ethical manner.

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. They also face potential audit risk which might prevent them from selling their approved product if they have been found to not have an IEC62304 Compliant Software Quality System. This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly so the software portion of the submittal will be in compliance preventing delays of the 510K approval.

Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars. Life supporting and life sustaining health software grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. FDA looks at software based on the risk to health associated with the software's use. Cybersecurity problems for software for life sustain devices, wireless networks for patient manage and home use devices open the gate for cyber intrusion, functional malware and total denial of access denial to an entire network of software, such as that used in hospitals and clinics. Who will help you? This becomes a self-help scenario; FDA and the FBI cannot protect you from the "bad guy."

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling Critical Path Analysis Value Stream Mapping Failure Mode Effects Analysis Process Improvement and Problem Solving: Reality Charting Model for Improvement

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include: Quality Management System / QA / QC Personnel, Facilities, Equipment Software controls Production and Process Controls Holding and Distribution Complaints and Returns Records

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward. The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU. Marketing Authorization holders of centrally authorized or mutually authorized [MRP /DCP] product licenses for pharmaceuticals and biologics along with CE-marked medical devices for human or veterinary use will have legal repercussions when the UK exits the EU.

In September of 2017, OCR shared preliminary results of their Phase 2, nation-wide, HIPAA Audits. As it relates to HIPAA Security Risk Analysis and Management the results were pretty shocking. OCR reported that 83% of those they audited had a score of "inadequate" or "failure" on their performance of an information security risk analysis while 94% had a score of "inadequate" or "failure" on their efforts of establishing or maintaining an information security risk management plan. A couple months ago the OCR announced their $3.5 million settlement with Fresenius Medical Care North America (FMCNA). The main reason cited by the OCR was that Fresenius "failed to heed HIPAA’s risk analysis and risk management rules." OCR Director Roger Severino had some very clear and strong words about the importance of performing a HIPAA Security Risk Analysis.

Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, new congressional mandates and any other applicable updates for 2019 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days - we will speak to the most common violations and fines - and how to best avoid fines and headaches. 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, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.

Overview: This 3-hour webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. We will go into detail about the 5 biggest "gotcha's" related to compliance with this enigmatic law. I will also speak of multiple litigated cases I have been involved with involving HIPAA compliance (or lack thereof). Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

Overview: We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why should you Attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party. They confirm the intentions and relationships of the parties as they enter into this relationship, and they eliminate uncertainties regarding mutual rights, obligations, and relationships.

Overview: Medical coding is the foundation of the US healthcare system. Medical codes are essential for billing and claims, reimbursement, healthcare analytics, risk scoring, physician compensation, among many other uses.Every claim includes multiple codes from various coding systems. This webinar explains the use of five of the most common schemes in use today: CPT and HCPCS codes, ICD-10 codes, DRGs, and APCs. For each system, we discuss how codes are assigned; where they appear on the claim; how they are used for billing and reimbursement; which types of claims are subject to each coding scheme; and other features of each system. We also provide tips for analyzing data containing these codes. Why should you Attend: Most healthcare workers use medical codes in one way or another in their jobs. To many people, coding systems such as CPT and ICD-10 can be confusing and hard to understand.

It seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used, including for health care purposes. New health care apps are being released all the time, and even good old e-mail is being used more and more to communicate, by providers and patients alike. In order to integrate the use of mobile technology into patient communications, it is essential to perform the proper steps in an information security compliance process to evaluate and address the risks of using the technology. This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate mobile technology into your organization in a compliant way. The process, including the use of information security risk analysis, will be explained, and the policies needed to support the process will be described But the process must also include consideration of various patient access requirements in the HIPAA Privacy Rule.

This session focuses on the issues of managing health information when it may involve substance abuse treatment information. HIPAA allows a number of disclosures without consent that SAMHSA prohibits without consent. First we will explain how HIPAA relates to information management and release and explain the processes required for various releases of information under the HIPAA rules, including release according to individual access requests, and under HIPAA authorizations. When substance abuse treatment information is involved, first you need to understand how to identify it. We will discuss how to make it distinguishable from "regular" health information, so that the appropriate extra protections can be provided. You may be able to use functions in your EHR to flag the information, or you may create a manual process for tracking the information, if it is rarely handled in your organization.

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2019. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors. We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations

Healthcare reimbursement systems can be complex and difficult to understand. Each payor may use a different method to reimburse providers, or they may use a variation of a commonly used method. This course will provide a foundation for understanding the common reimbursement systems in use today. We start with Medicare's reimbursement systems of RBRVS, DRGs, and APCs because many other payors use modified versions of these systems. We then discuss other payor types such as HMOs, PPOs, and ACOs and how these organizations use other reimbursement methods such as capitation, per diems, and carve outs. Finally, we discuss the key data elements needed to adjudicate claims according to each scheme, and we discuss the financial incentives (and disincentives) associated with each method.