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Courses

  • 21 Request Info

    Changes 2016 in HIPAA Privacy Security

    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/ Privacy world. I will discuss why the government is all of a sudden going full bore in demanding compliance. You will learn risk factors to avoid, best practices you should be doing, and how to be proactive in your efforts. In addition we are going to be discussing the methods in which patients can now sue under HIPAA and the steps they may be taking for civil remedy. On top of that what your practice or business needs to do so you can avoid the situation all together.
  • 22 Request Info

    Clinical Documentation Improvement: Moving to Improve Patient Outcomes

    Overview: Achieving high performing quality focused patient centered cost-effective outcomes based clinical care requires a multidisciplinary approach to delivering patient care. Why should you Attend: Accurate reporting and reflection of patient outcomes is paramount to success and exceling under value-based healthcare delivery and reimbursement models. The accuracy and completeness of input consisting of documentation that best communicates the patient encounter including need for care, investigation, treatment and outcomes drives patient care quality outcomes. Healthcare facilities and physicians face major opportunity costs and hurdles without solid consistent communication of patient care. A major limitation under the theory of limited constraints related to achieving high performing quality patient outcomes is the quality of the documentation of communication of patient care.
  • 23 Request Info

    Clinical Research Seminar 2016: Current Regulations under FDA and HIPAA

    Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information. Registration Link - http://bit.ly/2djQYsR-Human-Subjects
  • 24 Request Info

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 25 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.
  • 26 Request Info

    Conducting a Behavioral Health Risk Assessment

    Overview: There are some unique challenges to identifying the most significant compliance risks in the delivery of behavioral health services. This presentation will address both the risk assessment process and the specific risk areas associated with behavioral health.
  • 27 Request Info

    Contingency and Disaster Recovery Plan - Not What you Think

    Overview: HIPAA requires you to have both a Contingency Operations Plan and a Disaster Recovery Plan in place. In case you are wondering, being on a cloud-based EHR is not a Disaster Recovery Plan.
  • 28 Request Info

    Controlling Hazards in Spices : Basic Supply Chain Food Safety Control Requirements

    Overview With the finalization of the FDA’s FSMA Preventive Control Rules, new FDA outbreak testing technologies and increasingly complex supply chain controls, spices and other low moisture foods are becoming increasing identified as outbreak contributors. Spices are frequently found to carry salmonella, are full of physical adulterants, are often not identified as allergens, and may be impacted by lead and, when not carefully controlled throughout the supply chain, represent a bacterial growth potential that can end up in processed foods. Spice handling operations are subject to environmental facility controls, environmental sampling and test, process validation, Good Agricultural Practices (GAP), current Good Manufacturing Practices (cGPM), sanitary transportation rules, as well as packaging, labeling and other controls. For more detail please click on this below link: http://bit.ly/2ttPXYk Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515
  • 29 Request Info

    Current Regulatory Landscape with the new Canadian Cannabis Act

    Overview An overview of what the new Cannabis Act and related regulations and guidelines are, pertaining to the numerous Cannabis related activities in Canada and how it changed the broader regulatory environment. We will cover what this means to you according to the Cannabis activities sought, conducted or to be conducted. We will address a broad picture of how this new landscape impacts the regulatory process as it pertains to Cannabis for both recreational and medicinal use.
  • 30 Request Info

    Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

    Overview This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
  • 31 Request Info

    Dealing with the Disruptive Practitioner in a Legally Compliant Manner

    Overview: Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Why should you Attend: Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner's privileges and medical staff membership. You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior.
  • 32 Request Info

    Dealing with the Disruptive Practitioner in a Legally Compliant Manner

    Overview: Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Why should you Attend: Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner's privileges and medical staff membership.
  • 33 Request Info

    Designing Stark Compliant Physician Compensation Models

    In this webinar speaker will discuss common compensation model structures in the industry, Also discuss Best Practices for Auditing Compensation Plan Implementation.
  • 34 Request Info

    Digital Marketing for Healthcare - Connecting Audience to Industry Online

    This webinar offers guidance to build and maintain a systematic, affordable marketing effort to meet the needs of your organization within budgetary restraints, Also attendees will learn how to hire the right vendors, consultants, or develop staff internally for sustainable results.
  • 35 Request Info

    Drafting and Negotiating Physician Employment Contracts

    The webinar will focus on key regulatory requirements, key provisions, compensation and valuation considerations and potential pitfalls that should be avoided.
  • 36 Request Info

    Fair Market Value and Commercial Reasonableness in Physician Transactions: Complying With the Anti-Kickback and Stark Laws

    In this webinar speaker will Discuss the regulatory guidance and agency commentary on FMV and CR, and Provide perspectives on common misunderstandings and misconceptions related to FMV and CR, also discuss Emerging best practices for documenting fair market value and Commercial Reasonableness within Fragmented Health Care Organizations.
  • 37 Request Info

    FDA 21 CFR Part 11

    Overview This webinar will show you that there is no sense in tackling the 'keeping' of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records. If you are part of the process of 'Collecting' (e.g.: from study nurse to x-ray specialist), 'Using' (e.g.: from sponsor to report programmer, or statistician), or 'Keeping' (e.g.: from coder, software provider, to server and backup specialist), then this webinar will answer the questions: of how important your part is in this process, and how you can help the company safe resources and be compliant. If an effort is made to collect research-, study-, patient- or other important records, they should be kept safe, in a controlled and organized way. That way is defined by the requirements.
  • 38 Request Info

    FDA Scrutiny of Promotion and Advertising Practices 2017

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO
  • 39 Request Info

    FDA's Gluten-Free Labelling Rule: How to Comply

    Overview The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten-free products are a necessity. To help assure customer confidence, the FDA issued a final rule on August 5, 2014, that defines gluten-free claims across the food industry.
  • 40 Request Info

    FDA's New Import Program for 2019

    Overview The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information