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  • 41 Request Info

    Applied Statistics, with Emphasis on Risk Management 2017- Before 30 April 50% Discount for its All Seminars

    The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900928SEMINAR?trainingregistry_SEO
  • 42 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place.
  • 43 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC) 2017

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: • Total Product Life Cycle and Your Medical Device • An Overview of U.S. FDA Medical Device Regulation • Regulations for Design and Product Development • Premarket Notification - 510(k) and Premarket Approval (PMA) • Regulations for Production & Process Control • Readiness for FDA Facility Inspection Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2fGMba3-US-FDA-Laws Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 44 Request Info

    ARC014 - ARC's Forensic Accounting Course: Developing the Fraud Resistant Company®

    Latest results show that employees, customers and suppliers, steal over 7% of your company’s revenues. You will learn how to create a "Fraud Resistant Organizationy®" by analyzing the structure of your key accounting and operational systems In this hard hitting program, you will see how crooks have taken advantage of systems that may be in your own organization, and learn how to create the “Fraud Resistant Company®!” While no one can guarantee to “Fraud-Proof” a company, this program will show you haw to make the commission of a crime more difficult, and how to establish an “Early Warning System” for early detection. By a combination of learning from the significant cases of fraud in the past, coupled with a structured Risk Analysis of the processes in place today, you will learn how to make your key accounting and operational systems a crook’s “Worst Nightmare!”
  • 45 Request Info

    Assurances: What are they, Why and When do I need them

    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 agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions. Price - $139 Contact Info: Netzealous LLC -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/ Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/
  • 46 Request Info

    Auditing Physician Contracts for Compliance With the Stark Law and Anti-Kickback Statute

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law and Anti-Kickback Statute.He will also discuss best practices for auditing physician contracts on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: This webinar will offer best practices for implementing and auditing physician contracts to minimize liability and penalties. Areas Covered in the Session: Provide a general Stark and Anti-Kickback Overview Examine critical regulatory requirements related to physician compensation arrangements Review processes for documenting fair market value and commercial reasonableness Discuss best practices for auditing physician compensation arrangements and potential pitfalls Discuss how to resolve issues that may arise during the audit process
  • 47 Request Info

    Auditing Physician Contracts for Compliance With the Stark Law and Anti-Kickback Statute

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law and Anti-Kickback Statute. He will also discuss best practices for auditing physician contracts on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: This webinar will offer best practices for implementing and auditing physician contracts to minimize liability and penalties. Areas Covered in the Session: Provide a general Stark and Anti-Kickback Overview Examine critical regulatory requirements related to physician compensation arrangements Review processes for documenting fair market value and commercial reasonableness Discuss best practices for auditing physician compensation arrangements and potential pitfalls Discuss how to resolve issues that may arise during the audit process
  • 48 Request Info

    Auditing Physician Contracts Under the New Stark Rules

    Healthcare reform has invigorated the government's focus on healthcare fraud, including enforcement of the Stark Law. Improper design and implementation of physician arrangements can result in penalties, denial of payments, and exclusion from federal health care programs. Thus, ensuring Stark Law compliance will be critical for medical groups, hospitals and health systems looking to manage areas of enterprise risk. Health care organizations should periodically audit their existing arrangements to ensure they are compliant with Stark's technical requirements and key tenets of defensibility (e.g.fair market value, commercial reasonableness, and not taking into account designated health service referrals, etc.) in case their physician compensation arrangements are ever challenged.
  • 49 Request Info

    Auditing Physician Contracts Under the New Stark Rules 2018

    In this session Mr. Wolfe will provide an overview of the Stark Law, including its recent changes. He will also discuss best practices for auditing physician compensation arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. This webinar will offer best practices for implementing and auditing physician compensation arrangements to minimize liability exposure and penalties, including conducting compliance audits, instituting policies, and establishing ongoing monitoring and reviews.
  • 50 Request Info

    Avoiding the Legal Landmines of Employee Separation and Release Agreements

    . This OnDemand Webinar will address avoiding the legal landmines of employee separation and release agreements.
  • 51 Request Info

    Best Practice When Assessing Social Communication with High Functioning Autism Spectrum Disorders

    It is well known that individuals with High Functioning Autism Spectrum have deficits in social-communication skills. Engaging in one-sided conversational topics that hold little interest to others, a tendency towards hyper-literalism, an inability to understand idiomatic and abstract language are often present. Vocal tone may be flat and monotonous or may come across as condescending or outright oppositional. Add to this problem, the individual may have poor facial expressions which further serve to negatively impact how others perceive them socially. Reading nonverbal language is often a weak skill for individuals with High Functioning Autism Spectrum. What many people fail to realize is how significant a role this skill plays in social situations.
  • 52 Request Info

    Best Practices for FDA Inspection 2016

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.
  • 53 Request Info

    Best Practices for FDA Inspection 2016

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. Venue: Embassy Suites Boston at Logan Airport Address: 207 Porter St. Boston, MA 02128
  • 54 Request Info

    Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
  • 55 Request Info

    BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

    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.
  • 56 Request Info

    Building Employee Skills to Prevent Sexual Harassment

    This one-day skill-building participant-centered workshop uses interactive exercises, self-assessments, case studies, and simulations to enable employees to accept their responsibility for avoiding and preventing sexual harassment in their work groups. The employees are given the opportunity to: define what constitutes sexual harassment, assess their own myths and biases, and clarify when and how they should intervene when they become aware of an actual or potential sexual harassment situation. When they complete the workshop, they should have a clear understanding of the organization's policy prohibiting sexual harassment and their performance expectations as employees to follow this policy through word and deed.
  • 57 Request Info

    Burning Up While Burning Out - Compassion Fatigue Awareness & Burnout Prevention for Practitioners

    Overview: Healthcare professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many healthcare workers are putting in longer hours and for less pay. From working twenty-four shifts to simply burning the midnight oil catching up on paperwork, the healthcare industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Healthcare professionals bare witness to human suffering on a routine basis and are constantly reminded that tragedy, pain, and challenge often loom large in the midst of helping patients heal. As a result, compassion fatigue and burnout are major hazards of the profession that are becoming far too common. Price - $139 Contact Info: Netzealous LLC - MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/
  • 58 Request Info

    Business & Practitioner Resilience in Clinical Practice

    This training introduces and discusses resilience in healthcare practice in five general areas. Each of the areas or modules is extremely important to the success and continued growth of your practice. Regardless of whether you are a general medical practitioner or a specialist in practice, or whether you are in a solo or group practice, working diligently and dealing effectively with ongoing adversity is your key to a more resilient practice.
  • 59 Request Info

    Business Associates - What to Expect in 2019 - 5 Steps to HIPAA Compliance

    The HIPAA Compliance Official Who's in charge? - All HIPAA compliance responsibility rests squarely with top management. But authority to develop and implement a HIPAA compliance program is delegated to one or more Business Associate HIPAA Compliance Official(s). They must do more than just develop and implement Security Rule Policies and Procedures. Business Associate HIPAA Compliance Official's duties are a roadmap to develop, implement and maintain a Business Associate's HIPAA Compliance Program
  • 60 Request Info

    Business Associates 2017 - 5 Top HIPAA Compliance Priorities

    Overview: This session will explain Business Associate HIPAA compliance responsibilities There is a secret to Business Associate HIPAA compliance. The secret is - HIPAA Rules are easy to follow, step-by-step - when you know the steps. Why should you Attend: Business Associates organizations that create, receive, maintain or transmit Protected Health Information (PHI) on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity are directly liable for compliance with HIPAA law protecting the privacy and security of PHI. If you are a Business Associate you must know exactly what you have to do to comply with HIPAA. But you have two hurdles. First, your HIPAA responsibilities are new so you don't have the HIPAA compliance background and experience of your customers - Covered Entities.