GlobalCompliancepanel

Shahanshah Manzoor

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them: Risk Management Regulatory Compliances Corporate Governance Quality Management

Offerings

Showing 1-25 of 1941 results
  • COURSES: Structuring Physician Employment Agreements: Key Stark Law Considerations

    In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician employment agreements on behalf of health systems, hospitals and medical groups. He will explain key provisions and potential pitfalls in both types of agreements.
  • COURSES: HIPAA Compliant Patient Engagement - New Rules Webinar

    This webinar focuses on HIPAA Rules for transmitting informational email and text messages to patients over an electronic communications network. You will learn: The information that makes a message subject to HIPAA The "safe harbor" - How Health Care Providers may obtain consent from patients to send PHI in unencrypted email and unencrypted text messages and not be responsible for unauthorized access to the PHI in transmission or when received by the patient What a Health Care Provider must do if a patient does not agree to receive PHI in unencrypted email or unencrypted text message The requirements for a Business Associate to be able to communicate by email or text message with a patient on behalf of a Health Care Provider How a Business Associate may protect itself from liability for violating HIPAA Rules about email and text messages in its Business Associate Agreement
  • COURSES: Webinar On 3-Hour Virtual Seminar on MACRA & MIPS - HIPAA Rules for Text Messaging & Email

    Patient Engagement is widely recognized as essential for improving the quality of healthcare in the United States. Coordination of Care through Patient Engagement is a cornerstone of MACRA and revisions of Federal healthcare payment policy. Certified Electronic Health Record Technology (CEHRT) includes secure patient portals and secure messaging. Encrypted text message and email products are available from vendors. But patients overwhelmingly choose easy-to-use unencrypted email and text messaging systems. Tens of thousands of unencrypted appointment reminders, healthcare instructions, patient satisfaction surveys, health and wellness newsletters and recall reminders are sent every day exposing Healthcare Providers to unnecessary, easily avoidable risks. HIPAA provides a simple, but little known "Safe Harbor" for Healthcare Providers that permits unencrypted email and text message transmissions to a patient.
  • COURSES: HIPAA Texting and Emailing: Do's and Don'ts

    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. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • COURSES: 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.
  • COURSES: Webinar On Upcoming Changes with HIPAA - 2018

    This lesson 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 and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • COURSES: Developing 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. If your healthcare practice, business, or organization needs to understand how develop, maintain and modify HIPAA policies and procedures, please join us for this informative and interactive course.
  • COURSES: HIPAA Training for the Compliance Officer

    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 2018. 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 all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers. 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.
  • COURSES: HIPAA and Health IT - What you Need to Know as a Business Associate

    As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate. The HITECH Act, a recent update made to overall HIPAA regulations require Business Associates to comply with HIPAA mandates regarding the handling and use of health information. As a Business Associate you must comply with a wide-range of regulatory obligations, including certain privacy obligations, security standards, and breach notification requirements.
  • COURSES: HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

    This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. 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 18 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.
  • COURSES: Course On Business Associates 2017 - 5 Top HIPAA Compliance Priorities

    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. Second, you are liable for compliance with the entire HIPAA Security Rule - and parts of the HIPAA Privacy and Breach Notification Rules
  • COURSES: Webinar on HIPAA Requirements for Safeguarding Protected Health Information

    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. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding the fundamentals of a HIPAA compliance. If your healthcare practice, business, or organization needs to understand what is required to protect health records or make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course.
  • COURSES: Conducting an Effective Job Safety Analysis (JSA) - Job Hazard Analysis (JHA)

    A Job Safety Analysis (JSA) or Job Hazard Analysis (JHA) is a very effective way to help mitigate health and safety hazards in the workplace. A JSA/JHA is an important element to have in a comprehensive Safety and Health Management System. A JSA/JHA is a 3 step process that helps prevents Employee accidents and injuries. The first step of a JSA/JHA identifies all of the sequential steps of how a job or job task is done. The second step lists all health and safety hazards identified in the job or job process. The third and most important step identifies safety mitigation steps to prevent Employee injuries from occurring on that particular job. This webinar will cover how to effectively create and implement JSAs/JHAs in the workplace to prevent Employee injuries.
  • COURSES: Webinar On HIPAA Enforcement Activity - Learning from the Mistakes of Others

    Now that the HIPAA rules have been in place for more than a dozen years, the days of advice and counseling have been replaced by a hard-nosed enforcement attitude, where HHS OCR is ready to make health care organizations that violate the rules feel some pain for their actions. If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. In addition, HIPAA enforcement has taken on a new importance at HHS; officials have publicly stated that enforcement is now a priority, and that means being ready for an audit or compliance review is more important than ever.
  • COURSES: Webinar On 2018 HIPAA Changes and Beyond

    This lesson 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, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. 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. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • COURSES: Webinar On HIPAA - How to Put a Compliance Program in Place

    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. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.
  • COURSES: How Ensuring Data Integrity in Method Validations

    Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend: The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity.
  • COURSES: NDAs and INDs for Orally-Administered Drug Products

    Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: Understanding when Bioavailability and Bioequivalence studies should be done can help attendees avoid having to re-do clinical trials, help to determine dosage regimen that achieves target drug exposure.
  • COURSES: Learn Some of the Acceptance Activities in FDA QSR

    Overview: This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Why should you Attend: As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
  • COURSES: Underutilized and Underappreciated in Management Control

    Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Why should you Attend: Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus.
  • COURSES: How to Comply with both in the Same Organization

    Overview: This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. Why should you Attend: For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.
  • COURSES: Final Rules of Unique Device Identification

    Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled. Why should you Attend: It will also review the implementation schedule which is required of medical device companies selling products in the U.S. This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA.
  • COURSES: How to plan risk based approaches for clinical trials

    Overview: You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials. Areas Covered in the Session: Have explained key risk based process/tools and techniques Review a risk based approach to protocol design Understand risk based approach to monitoring / data handling Review of risk based approaches to QC / QA (Auditing) Hear best practice of these new risk requirements
  • COURSES: Practices for Active Pharmaceutical Ingredients per ICH Q7

    Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend: This document was created to fulfil the need for specific guidance with regards to GMPs for APIs. Failure to meet these requirements is a significant source of observations during regulatory inspections by FDA or global regulators of manufacturers and/or of sponsors that use contract manufacturers and the contract manufacturers themselves.
  • COURSES: Why Capturing Justifications in Change Control

    Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result. Areas Covered in the Session: Determine alternatives or options to the proposed solution Analyze costs, benefits, impacts, and risks of the proposed solution Validate the solution, assess product impact to the market

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18004479407

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