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 1637 results
  • COURSES: FDA inspectional - Training Practices for FDA Compliance - 2017

    Overview: Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. Areas Covered in the Session: GxP training requirements in US and EU Most frequently cited deviations
  • COURSES: Best Practices & Effective Cleaning Validation Procedures - 2017

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why should you Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment?
  • COURSES: Clinical Trials - Medical Device FDA's Program 2017

    Overview: The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Why should you Attend: In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial.
  • COURSES: Excel Methods - FDA Device Regulations - 2017

    Overview: FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations and their application. The presentation begins with Excel methods to help ensure the spreadsheet produces the results you want. Why should you Attend: Excel workbooks must produce correct results, so the first concept helps ensure correctness. Excel workbooks may also cause regulatory problems, because they are easy to implement and very common. Often people that improve processes with these workbooks are not aware of the regulatory requirement.
  • COURSES: ISO 14971 Hazard Analysis at Medical Device - 2017

    Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
  • COURSES: Laboratory-Developed Tests - Medical devices 2017

    Overview: This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. Why should you Attend: This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.
  • COURSES: Environmental Monitoring Program at FDA Regulations - 2017

    Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring. Why should you Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment?
  • COURSES: FDA Inspection and Respond to 483 & How to Prepare them - 2017

    Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
  • COURSES: Validation Program to a Building from Top to Bottom - 2017

    Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.
  • COURSES: Effective Supplier Qualification Program - 2017

    Overview: FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. Areas Covered in the Session: Learn the pre-selection, selection and assessment process through the use of various tools Methods, techniques and strategies that work and are proven with supplier relations and qualification
  • COURSES: Cyber Attacks, Beyond Disaster Recovery - 2017

    Overview: Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Why should you Attend: A poor response is often more damaging that the cyber-attack itself. According to recent reports, cyber-attacks cost the average American business $15.4 million per year, double the global average of $7.7 million.
  • COURSES: Structuring Physician Practice Acquisitions: Key Stark Law Considerations webinar by MentorHealth

    Overview: 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 administrative 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. Why should you Attend: As health care organizations and physician practices pursue acquisition strategies and transition to more innovative post-transaction models, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law.
  • COURSES: Webinar on HIPAA for HR - Some Good News for Employers

    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, and employer-based health plans are no exception. In order to determine their HIPAA compliance obligations, employers need to go through an analysis of their health insurance offereings for their employees. Employers need to examine, is the plan insured or self insured, is it one plan or several, do they rely on an insurer for all the functions or do they use a third party administrator, and much more. Much of the determination of how to comply depends on how involved the employer is with the operation of the plan and the kinds of information the employer receives about the health plan.
  • COURSES: Webinar on 2017 HIPAA Audits - an Insider's Perspective

    I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. This lesson 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 2017. 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 and practice managers.
  • COURSES: Structuring and Auditing Medical Director Arrangements: Key Stark Law Considerations

    Overview: 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 administrative 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. Why should you Attend: As health care organizations and physicians develop administrative arrangements, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law.Prior to moving forward with any arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the arrangement is ever challenged.
  • COURSES: 2017 Webinar on HIPAA and Personal Devices

    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: European Regulatory Procedures 2017

    EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation. Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network. And Much More...
  • COURSES: HIPAA 2017 Under Trump 2017

    The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises, and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways Thorough Understanding of HIPAA Rules What they are How they work together Why and how they were made How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization A Practical Guided Exercise done in class on your computer to take home Privacy and Security Rules - Permitted and Required Uses and Disclosures What information must be protected Administrative, Technical and Physical Safeguards Social Media, Texting and Emailing Patients
  • COURSES: Lineament analysis and Quality Assurance and Quality Control procedures 2017

    Upon completing this course, participants should: Understand the limitations of the current exploration process Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts How to implement QA&QC; procedures to guarantee the quality of the collected data Why you should attend: We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information, we are able to help you concentrate your exploration efforts to keep your budget in the black. Appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to ensure that the best possible confidence in resultant mineral resource and reserve estimates are achieved, as the quality of an estimate is dependent on the quality of the data used.
  • COURSES: 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. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line
  • COURSES: Root Cause Analysis and CAPA using 8-D Problem Solving Method 2017

    Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a bandaid on it) while identifying the Root Cause(s), and take steps to address the problem in the short term as well as in the long term (permanent fix). In this interactive workshop, you'll learn how to apply the many tools used to identify possible causes, determine (with data) which is the true root cause (or causes, as there may be some compounding of problems occurring), and how to fix them - permanently. 8D is used by a wide variety of industries - from service to design, manufacturing, and fulfillment. 8D has been used by sales forces
  • COURSES: Quality Management System ISO 13485- 2017

    The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue
  • COURSES: The Challenges of an Effective Change Control Program 2017

    An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control. This seminar will concentrate on three major points: The regulatory requirements for change control and what it applies to. How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators. What are some of the common deficiencies cited by regulatory auditors?
  • COURSES: HIPAA Compliance Requirements for Business Associates 2017

    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, requires 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. If your business needs to understand what it means to be a Business Associate and know what required safeguards, policies
  • COURSES: Documenting Software for FDA Submissions 2017

    When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto. The Agile approach helps companies avoid hearing bad news late in a project, by delivering incrementally, integrating regularly, and leaving room for learning as the user stories are refined. In addition, it provides real information on progress and project speed to stakeholders outside the development group. Documentation under Agile, then, can take advantage of iterative development. Each objection to Agile reveals another point of discipline for effective Agile teams. Requirements can be captured

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161| Mission Falls Lane| Suite 216, Fremont| CA 94539
Fremont, CA 94539
US
18004479407

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