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  • 1 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 2 Request Info

    Your Organization's Culture: If You Don't Get It Right, Nothing Else Matters - By Compliance Global Inc.

    Get on a Southwest flight to anywhere, buy shoes from Zappos.com, pants from Nordstrom, groceries from Whole Foods, anything from Costco, a Starbucks espresso, or a Double-Double from In N' Out, and you'll get a taste of these brands’ vibrant change management trainingcultures. Unfortunately,changing company culture is often misunderstood and discounted as a touchy-feely, rather than a bottom line, component of a business. That’s not the case. As Peter Drucker, the founder of modern management said, “Culture eats strategy for lunch.” Changing culture in the workplace is one of the most important business drivers that must be intentionally set and periodically adjusted to push long-term, sustainable success. It's not good enough just to have an amazing product and a healthy bank balance. The workplace culture can enable company culture ideas, or be the key to its undoing.
  • 3 Request Info

    The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900936SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 4 Request Info

    FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900944SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 5 Request Info

    2017 Webinar on HIPAA -Emailing and Texting

    Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. 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. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 6 Request Info

    HIPAA Texting and Email with Patients

    This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. The session will explain how to discuss communications options with individuals so that you can best meet their needs and desires, while preserving their rights under the rules. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 7 Request Info

    Webinar on Auditing Physician Contracts Under2017 Stark Rules

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law and its 2017 changes. He will also discuss 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 review processes. Why should you Attend: Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems pursue integration strategies and transition to more innovative hospital-physician arrangements, these organizations must manage their compliance and enterprise risk by ensuring their compensation arrangements are defensible under the Stark Law. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 8 Request Info

    Injections vs Creams. Which is most effective?

    Overview: The most popular cosmetic injection treatments include Hyaluronic acid,collagen and Botox. Hyaluronic acid absorbs about 1000 times its weight of water and as a result is good for plumping of lips. Collagen is a good filler and provides elasticity to collagen deprived skin, a condition which increases with age.Botox is used for facial wrinkles and in particular expression wrinkles. Injections have both pro and con attributes. The positive side is immediate results the negatives consist of expense and discomfort although microneedles have mitigated the latter Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 9 Request Info

    Webinar on HIPAA Hot Topics and Current Trends

    Overview: This timely presentation delivers an update of the most important healthcare privacy and security rule / guidance regulatory changes, including but not limited to, HIPAA. The session also covers some evolving best practices that address these rule changes. The presentation is intended to impart a large volume of information about the rapidly changing regulatory privacy and security environment in a relatively short timeframe with comprehensive slide content useable by attendees after the presentation as they adopt and train others on these subjects. Mr. McLendon is well known for condensing and simplifying the complex presentation content into easily learnable points with his signature delivery style. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 10 Request Info

    New HIPAA Audit and Enforcement Activities Webinar

    Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits.We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most.We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the next round. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 11 Request Info

    Webinar on HIPAA -and Personal Devices

    Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. 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 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. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 12 Request Info

    How to Develop HIPAA Policies and Procedures

    Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. A HIPAA Risk Management plan is your overall policies and procedures manual. If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards. If audited by HHS, being able to demonstrate HIPAA compliance will involve providing many of these policies and procedures. Having a fundamental understanding of a HIPAA compliance helps to know what is required to implement those policies and procedures. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 13 Request Info

    Webinar on Understanding Autism Spectrum Disorder (ASD)

    Overview: "As he sits in class at Eastern Michigan University, a flood of images streams from Tony Saylor's vibrant, creative mind down through his pen and onto paper. Often, his doodling features the 9-year-old character Viper Girl who battles monsters with her pet fox Logan. Saylor, 22, has even self-published three books of their adventures. Saylor's professors didn't exactly welcome his constant drawing, but once he explained it was the only way he could hope to process their lectures -and even to stay awake -most let him continue. For college students with autism and other learning disabilities, this is the kind of balancing act that takes place every day -accommodating a disability while also pushing beyond it toward normalcy and a degree, which is increasingly essential for finding a meaningful career." - The Huffington Post (2013) Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 14 Request Info

    Webinar on OIG Work Plan 2017

    Our discussion will provide a summary of all audit and enforcement activities in the 2017 Work Plan, with a focus on new or revised hospital risk areas such as: 1. Hyperbaric Oxygen ("HBO") Therapy Services 2. Incorrect Medical Assistance Days Claimed by Hospitals 3. Inpatient Psychiatric Facility Outlier Payment 4. Intensity-Modulated Radiation Therapy ("IMRT") We will discuss the ongoing activities and also "Other Providers" audit activities, including methods on how to conduct internal monitoring for compliance. Why should you Attend: Compliance, billing and healthcare operations will benefit by understanding the new additions to this year's OIG Work Plan, as well as ongoing audit activities that may affect their organizations. The Work Plan should be reviewed to determine areas that may be at risk and require audit or monitoring activities. Contact Info: Netzealous -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com
  • 15 Request Info

    Webinar on Medical Necessity: Can you define it, Capture it, Document it

    Overview: This webinar will address the various methods of ensuring appropriate documentation to identify Medical Necessity for services provided. An area that is often over looked is the significance of the medical coding from Hospitalization to Home Care and the skilled nursing facility between. With the new coding guidelines for ICD-10,our use of documentation is essential,as we are required to support the services we provide with not only the correct coding but the documentation to match the coding.
  • 16 Request Info

    2017 Health Care Contracting Toolkit Best Practices

    Training Options Duration: 60 Minutes Monday, April 3, 2017 | 10:00 AM PST | 01:00 PM EST Overview: This webinar will include a "Contracting Toolkit" of best practices that health care organizations can follow to avoid compliance traps related to the technical requirements for payments to physicians and the Three Key Tenets of Defensibility: fair market value, commercial reasonableness, and not taking into account volume or value of referrals. The session will also recap trends in government and whistleblower enforcement.
  • 17 Request Info

    Medical Devices Industry and Risk Management 2017

    Gaps, incorrect or incomplete implementation of software 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 18 Request Info

    Conducting Internal Investigations 2017

    t seems that employees love to complain about anything, and it seems impossible to investigate everything. When employees feel, however, that you are not taking their complaints seriously enough or that you are ignoring them, they will find external sources for their complaints. These external sources range anywhere from the EEOC, the NLRB, Wage and Hour, private attorneys, and juries!! And juries love to punish you when they feel that you ignored an employee's legitimate complaint. But what are legitimate complaints? We all know that an employer has a legal responsibility to investigate some complaints but not others. Can you make the distinction? How you handle internal complaints can make all the difference of whether an employee goes externally with their complaints. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900872SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 19 Request Info

    Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

    Why Should You Attend? By attending, you will take advantage of a great opportunity to advance as a manager to the next level! Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again! We'll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up. Join us as we help you report back to your manager that "I'm ready to take the next step in advancing my management career!" Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900866SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 20 Request Info

    Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

    This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered: History and background of U.S FDA Laws and Regulations Classify Your Device Choose the Correct Premarket Submission for your device Compile the Appropriate Information for your Premarket Submission Author and Prepare your Premarket Submission Submit your Premarket Submission to the FDA Interact with FDA Staff during Review and Approval Complete the Establishment Registration and Device Listing Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900778SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO